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Antibiotic prophylaxis for preventing burn wound infection

  1. Leticia A Barajas-Nava1,*,
  2. Jesús López-Alcalde2,
  3. Marta Roqué i Figuls3,
  4. Ivan Solà3,
  5. Xavier Bonfill Cosp4

Editorial Group: Cochrane Wounds Group

Published Online: 6 JUN 2013

Assessed as up-to-date: 31 JAN 2013

DOI: 10.1002/14651858.CD008738.pub2

How to Cite

Barajas-Nava LA, López-Alcalde J, Roqué i Figuls M, Solà I, Bonfill Cosp X. Antibiotic prophylaxis for preventing burn wound infection. Cochrane Database of Systematic Reviews 2013, Issue 6. Art. No.: CD008738. DOI: 10.1002/14651858.CD008738.pub2.

Author Information

  1. 1

    Institute of Biomedical Research (IIB Sant Pau), Iberoamerican Cochrane Centre, Barcelona, Barcelona, Spain

  2. 2

    Laín Entralgo Agency (Cochrane Collaborating Centre), Health Technology Assessment Unit, Madrid, Madrid, Spain

  3. 3

    CIBER Epidemiología y Salud Pública (CIBERESP), Spain, Iberoamerican Cochrane Centre, Institute of Biomedical Research (IIB Sant Pau), Barcelona, Catalunya, Spain

  4. 4

    CIBER Epidemiología y Salud Pública (CIBERESP), Spain - Universitat Autònoma de Barcelona, Iberoamerican Cochrane Centre, Institute of Biomedical Research (IIB Sant Pau), Barcelona, Catalonia, Spain

*Leticia A Barajas-Nava, Iberoamerican Cochrane Centre, Institute of Biomedical Research (IIB Sant Pau), C/ Sant Antoni Ma Claret 171, Casa de Convalescència, Barcelona, Barcelona, 08041, Spain. leticia.barajas@cochrane.es.

Publication History

  1. Publication Status: New
  2. Published Online: 6 JUN 2013

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Characteristics of included studies [ordered by study ID]
Alexander 1982

MethodsStudy design: randomised, prospective, double-blind trial.

Setting/location: hospital (Shriners Burns Institute Cincinnati Unit, Ohio). Country: USA.

Period of study: 2.1 years.

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: yes.


ParticipantsInclusion criteria:

1. Patients scheduled for clean reconstructive surgery involving skin grafts.

Exclusion criteria:

1. Patients who had grafts immediately adjacent to the mouth or anus.

2. Another indication for the administration of an antibiotic during the preoperative period of hospitalisation.

3. Presence of open areas in the anatomic preparation area of either the donor site or reconstructive site.

4. Known or suspected allergy to penicillin or to cephalosporins.

Randomised: 249 patients (Intervention group: n = 127, Control group: n = 122).

Withdrawals: Intervention group: 1 (2.5%) Reasons: adverse reaction.
Patients assessed: 249 (100%).

Age (years): (mean): Intervention group: 10.5 ± 0.4, Control group: 10.8 ± 0.4.

Burned surface (% TBSA): not described.

Inhalation injury: not stated.

Time post-burn (h): (mean): Intervention group: 72.5 ± 0.4, Control group: 71.0 ± 4.4.

Burn type: Intervention group: thermal (100%), Control group: thermal (100%).

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: systemic antibiotic prophylaxis (perioperative).

Type of interventions: cephalothin vs placebo.

Intervention group: iv cephalothin (Keflin, Eli Lilly, Indianapolis) 15 mg/kg in 50 ml of 5% dextrose in water.
Control group: placebo (identical volume of 50 ml of 5% dextrose in water).

1st dose given with preoperative medications, 2nd dose at start of skin incision, 3rd dose 4 h later during the recovery phase.

Duration of intervention: perioperative (1 day).

Co-interventions: not described.


OutcomesIncidence of infection graft (infection was defined as discharge of pus from the graft site associated with graft loss).

Adverse effects.

LOS (days).


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "After informed consent . . . patients were randomised by draw of a card in a sealed envelope according to the anatomic site of the operation" (Page 687).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskQuote: "After informed consent . . . patients were randomised by draw of a card in a sealed envelope according to the anatomic site of the operation" (Page 687).

Quote: "The sealed envelope designating whether or not the patient would receive the prophylactic antibiotic was identified on the outside by a research nurse with the patient's name, hospital number and weight in kilograms and given to the hospital pharmacist" (Page 687 trial report).

Comment: insufficient information to permit judgement of ‘low risk’ or ‘high risk’.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "The sealed envelope designating whether or not the patient would receive the prophylactic antibiotic was identified on the outside by a research nurse with the patient's name, hospital number and weight in kilograms and given to the hospital pharmacist. On the morning of operation, the pharmacist dispensed three doses of either the antibiotic or placebo . . . All of the doses of antibiotic or placebo were given intravenously by 'piggy-back' infusion, using identical infusion sets." (Page 687 trial report). "Only the pharmacist knew whether the patient received the antibiotic or a placebo until the end of the study" (page 688).

Comment: patients and key study personnel were probably blinded.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "Only the pharmacist knew whether the patient received the antibiotic or a placebo until the end of the study" (Page 688 trial report).

Comment: the outcome assessment was probably blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: no missing outcome data. All patients who were randomised were included in the final analysis. ITT analysis was conducted.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasLow riskThe study appears to have been free of other sources of bias.

Alexander 1984

MethodsStudy design: prospective, randomised trial.

Setting/location: hospital (Shriners Burns Institute Cincinnati Unit, Ohio). Country: USA.

Period of study: not stated (published in 1984).

Unit of randomisation: patient.

Unit of analysis: patient and procedure.

Sample size calculation: no.

Use of ITT analysis?: yes.


ParticipantsInclusion criteria:

1. Patients admitted to the Burns Center (acute care).

2. Burns of ≥ 20% of TBSA.

Exclusion criteria:

1. History of sensitivity to multiple antibiotics.

Randomised: 69 patients (Intervention group: n = 35, Control group: n = 34).

Withdrawals: not stated.

Burned surface (% TBSA):

20-50% TBSA: Intervention group: 19 (54.3%), Control group: 21 (62%).

≥ 50% TBSA: Intervention group: 16 (45.7%), Control group: 13 (38%).

Inhalation injury: not stated.

Time post-burn (h): not stated.

Burn type: not stated.

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: systemic antibiotic prophylaxis (perioperative).

Type of interventions: prophylactic antibiotics vs no prophylactic antibiotics.

Intervention group: prophylactic antibiotics during the perioperative period for debridement and skin grafting.

Selection of the antibiotic(s) for use was based upon antibiotic sensitivity of the dominant organism and most recent wound cultures. Antibiotics were not given at other times except for specific medical indications.

Control group: no prophylactic antibiotics.

Duration of intervention: perioperative (1 day).

Co-interventions: not described.


OutcomesInfection (total number of bacteraemic episodes/days at risk).

Postoperative blood cultures.

Mortality.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Patients were randomised to receive prophylactic antibiotics or no prophylactic antibiotics within the size ranges of 20-50 % and greater than 50% to assure equal distribution. Randomization was done at the time of admission and an attempt was made to place all control patients on one ward and all treatment patients on another ward" (Page 20 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo information provided.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information provided.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDid not report number of withdrawals.

Comment: denominator values suggested complete follow-up.

Selective reporting (reporting bias)High riskNo protocol provided. Not all of the outcomes reported were mentioned in the methods section of the paper (for example, mortality was not specified).

Other biasUnclear riskAlthough mentioned that the groups were homogeneous, no data on age, sex, or comorbidity in each comparison group were presented.

Ang 2001

MethodsStudy design: prospective, randomised, controlled clinical trial.

Setting/location: hospital (Singapore National Burns Center, Singapore General Hospital). Country: Singapore.

Period of study: 1 April 1997-24 October 1998 (1.6 years).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: yes. Quote: "All analyses were made using intention-to-treat" (Page 95).


ParticipantsInclusion criteria:

1. Age: ≥ 6 and < 80 years.

2. Partial-thickness burns.

Exclusion criteria:

1. Age: < 6 and > 80 years.

2. Electrical or chemical burns.

3. Burns > 40% TBSA.

Randomised: 115 patients (Group 1: n = 58, Group 2: n = 57).

Excluded (post-randomisation): Group 2: 3 (5.3%). Reason for exclusion: Quote: "In the MEBO group, data were not obtained from 3 patients (1 who was inadvertently randomised with BSA 68 %, technically violating the inclusion criteria, 1 illegal immigrant who was repatriated to his country of origin following first aid care, and 1 who withdrew consent immediately after randomisation for no specific reason)" (Page 95).

Withdrawals: Group 1: 2 (3.4%), Group 2: 1 (2%). Reasons: death.

Patients assessed: 112 (97.4%) Group 1: 58, Group 2: 54.

Age (years): (mean, range): Group 1: 33.7 (11-68), Group 2: 38.2 (7-68).

Gender (male: female): Group 1: 43 (74%): 15 (26%), Group 2: 40 (74%): 14 (26%).

Burned surface (% TBSA): (mean, range): Group 1: 8.7% (1.5-32), Group 2: 10.5% (1.5-37.5).

Inhalation injury: not stated.

Time post-burn (h): not stated.

Burn type: Group 1: fire (flame) 28 (48%), scald (hot liquid or steam) 22 (38%), other (several agents, oil scald) 8 (14%); Group 2: fire 29 (54%), scald 20 (37%), other 5 (9%).

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: SSD (conventional management) vs MEBO (traditional medicine).

Group 1: topical SSD twice daily.
Group 2: 4-hourly MEBO ointment (oil-based ointment containing sesame oil, beta-sitosterol, berberine, and other small quantities of plant ingredients).

Duration of intervention: 14 days.

Co-interventions: in the SSD group (designated "C" by the trialists), burns were cleansed with plain chlorhexidine 0.05 % and de blistered where necessary. Areas of superficial burns were covered with paraffin-impregnated gauze (Jelonet, Smith & Nephew Inc, Largo, Florida) or polyurethane dressing (Opsite, Smith & Nephew). In limited areas, not amenable to surgery with slough persisting beyond 14 days, chemical debridement using Elase (fibrinolysin and desoxyribonuclease) (Warner-Lambert, Parke-Davis) was used. In the MEBO group, the wounds were cleansed with normal saline gauze. In both groups, the excision and skin grafting were carried out on deep dermal wounds that showed minimal signs of healing after 14 days. Antibiotics were given only for clinically septic patients.


OutcomesWound healing rate.

Bacterial infection rate.

Burn wound infection (a clinical assessment was made daily for the presence of fever and/or reddening of the wound to indicate infection).


NotesConflict of interest: Quote: "None of the investigators maintain any financial interest in the company manufacturing MEBO" (Page 95 trial report).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "After the initial assessment, patients were randomly assigned to C or MEBO . . . Randomly alternating permuted sub-blocks of sizes 4 and 6, with equal numbers per treatment within each sub-block, were used to obtain an overall block size of 10" (Page 93 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Low riskQuote: "After the initial assessment, patients were randomly assigned to C or MEBO either by telephone to the National Medical Research Council Clinical Trials & Epidemiology Research Unit, Singapore (trial office), or by sealed envelopes. Envelopes were provided for patients requiring treatment allocation outside "office hours." These were numbered sequentially and a list was provided with the envelopes and completed with the trial number, allocated treatment, and patient name. The date the envelope was opened (i.e. the date of randomisation) was added. Notification of this procedure was sent to the trial office by facsimile". (Page 93 trial report).

Blinding of participants and personnel (performance bias)
All outcomes
High riskComment: there was no information about blinding of participants and personnel. Blinding can be difficult for this study due to the different nature of the interventions being evaluated (topical interventions with different characteristics are easily noticed). The antibiotic was applied topically, and, with different time points for applications, was obviously different to the intervention administered in the other (MEBO) group; we assumed that the participants, personnel or outcome assessors were not blinded.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information provided.

Comment: there was no information about blinding of outcome assessment. Blinding can be difficult for this study due to the different nature of the interventions being evaluated (topical interventions applied at different time points - easily noticeable).

Incomplete outcome data (attrition bias)
All outcomes
Low riskLosses and reasons for dropping out of the study were reported.

58/58 and 54/57 patients in the SSD and the MEBO groups, respectively, were included in the final analysis. ITT analysis was conducted.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes nominated in the methods section, all pre-specified outcomes were reported.

Other biasLow riskThe study appeared to be free of other sources of bias.

Barret 2000

MethodsStudy design: prospective, randomised study.

Setting/location: hospital (Shriners Burns Hospital and the University of Texas Medical Branch, Galveston). Country: USA.

Period of study: not stated (published in 2000).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: yes. Quote: "Based on previous studies published in the literature with similar populations,1–3 sample size was estimated at 20 patients (10 patients per group), taking a power of 0.80 and an alpha level of 0.05" (Page 62).

Use of ITT analysis?: yes.


ParticipantsInclusion criteria:

1. Age: 0-17 years.

2. Partial-thickness burns.

3. Burn type: thermal, flame or scald.

4. 2- 29% TBSA.

5. Admitted within 24 h of injury.

6. Clean wound, uninfected (diagnosed by the attending physician).

Exclusion criteria:

1. Age: > 17 years.

2. Full-thickness burns.

3. Admitted > 24 h after injury.

4. Other types of burn injuries (chemical, electrical, or contact).

5. Evidence of contaminated or infected wounds.

Randomised: 20 paediatric patients (Group 1: n = 10, Group 2: n = 10).

Patients assessed: 20 (100%).

Withdrawals: not stated.

Age (years): (mean): Group 1: 3.7 ± 0.6, Group 2: 3.1 ± 0.5.

Gender (male:female): Group 1: 8 (80%):2 (20%), Group 2: 7 (70%):3 (30%).

Burned surface (% TBSA): (mean): Group 1: 7.8% ± 0.9, Group 2: 8.9% ± 4.9.

Inhalation injury: not stated.

Time post-burn (h): < 24 h after injury (both groups).

Burn type: Group 1: fire (flame) 3 (30%), scald (hot liquid or steam) 7 (70%); Group 2: fire 2 (20%), scald 8 (80%).

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: SSD vs biosynthetic dressing.

Group 1: topical SSD 1% (Silvadene) twice a day.
Group 2: biosynthetic dressing (Biobrane - skin substitute). Application of a temporary cover to all open wounds.

Wounds were inspected within 24 h, and patients discharged when parents were ready to assume wound care.

Patients included in SSD group received wound care until wounds were healed.
Patients dressed with Biobrane received no other treatment until wounds were considered to be healed.

Duration of intervention: until wounds healed.

Co-interventions: before wound debridement, all patients were sedated with ketamine (1 mg/kg iv or 4 mg/kg intramuscularly). Pain medication regimen included 0.3 mg/kg/dose morphine by mouth for procedural pain and acetaminophen 15 mg/kg/dose by mouth every 4 h for background pain. The anxiolytic regimen included 4-hourly Lorazepam, 0.03 mg/kg/dose by mouth.


OutcomesWound healing time (days): wounds were considered healed when all areas affected in the initial injury were closed.

LOS (days).

Infection.

Wound infection.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "After obtaining informed consent as mandated by the University of Texas Medical Branch Institutional Review Board, patients included in the study were randomised into two groups" (Page 63 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
High riskIt was not reported whether participants and personnel were blinded but, due to the different nature of the interventions (SSD versus biosynthetic dressing), they were probably not blinded.

Blinding of outcome assessment (detection bias)
All outcomes
High riskQuote: "Pain assessment was not blinded due to the nature of the study" (Page 63)"

Comment: outcome assessment was not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDid not report number of withdrawals.

Comment: all patients who were randomised were included in the final analysis. ITT analysis was conducted.

Selective reporting (reporting bias)High riskNo protocol provided, and some of the outcomes reported were specified in the methods section of this paper.

Other biasLow riskQuote: "Patients included in both groups were comparable, and all data followed normal distribution (Kolmogorov- Smirnov normality test)" (Page 63 trial report).

Barret 2001

MethodsStudy design: prospective, randomised, double-blinded study.

Setting/location: hospital (Shriners Burns Hospital Galveston and The University of Texas Medical Branch). Country: USA.

Period of study: 9 months.

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: yes.

Use of ITT analysis?: yes.


ParticipantsInclusion criteria:

1. Age: 0-18 years.

2. Full-thickness burns.

3. Burns ≥ 30% TBSA

4. Admission within 5 days of injury.

5. No evidence of sepsis or organ failure.

Exclusion criteria:

1. Evidence of sepsis or organ failure.

Randomised: 23 patients (Intervention group: n = 11, Control group: n = 12).

Age (years): (mean): Intervention group: 8 ± 1, Control group: 9.4 ± 2.

Burned surface (% TBSA): (mean, SEM): Intervention group: 67% ± 6, Control group: 58% ± 6.

TBSA full thickness burns: (mean, SEM): Intervention group: 59% ± 6, Control group: 54% ± 6.

Inhalation injury: Intervention group: 9/12 (75%), Control group: 7/11 (64%).

Time post-burn: < 5 days from injury.

Burn type: not stated.

Wounds infected at baseline?: no.

Co-morbidity: not stated.


InterventionsType of antibiotic prophylaxis: non-absorbable antibiotic prophylaxis (selective digestive decontamination).

Type of interventions: selective digestive decontamination vs placebo.

Intervention group: suspension of polymyxin E (100 mg), tobramycin (100 mg), and amphotericin B (500 mg) given by nasogastric tube, 4 times/day.
Control group: isotonic physiologic solution (Ringer's lactate).

Duration of intervention: until open burn wound area < 10% TBSA (48 days).

Co-interventions: resuscitation was given immediately after burn wound (lactated Ringer’s solution). Within 24 h of admission, patients underwent total burn wound excision of all full-thickness burns, and coverage with autografts and homografts. Systemic antibiotics (vancomycin, amikacin, and piperacillin) were given preoperatively before 1st operative session in order to prevent postoperative sepsis due to perioperative bacteriaemia. All patients received nasoduodenal feedings with Vivonex TEN (Sandoz Nutrition, Minneapolis, MN), an elemental formula containing 82.3% carbohydrate, 3% fat (linoleic acid), and 14.7% protein. Oral nystatin in the form of ‘swish-and-swallow’ was used to prevent oral and oesophageal candidiasis.


OutcomesEpisodes of pneumonia (with positive bacteria and white cells on a class III, or sputum specimen).

Episodes of sepsis (positive blood culture).

Episodes of diarrhoea (culture results from faeces).

Episodes of UTI (with 105 organisms/ml urine).

Wound infection (biopsy with more than 105 organisms/g tissue and/or histologic evidence of viable tissue invasion).

Time until wound closure (days).

Miscellaneous complications.

LOS (days).

Mortality.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Randomization was performed with a random-number chart (Page 440), "Randomization was stratified for age, time from burn to admission, burn size, and presence of inhalation injury and ventilatory support" (Page 441 trial report).

Allocation concealment (selection bias)Low riskCentral allocation at pharmacy.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "The study drug was prepared by the pharmacy and all patients, physicians, microbiologists, nursing staff, dieticians and laboratory personnel were blinded" (Page 440 trial report).

Comment: participants and personnel were probably blinded.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "The study drug was prepared by the pharmacy and all patients, physicians, microbiologists, nursing staff, dieticians and laboratory personnel were blinded" (Page 440 trial report).

Comment: outcome assessment was probably blinded.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNumber of withdrawals not reported.

Comment: all patients who were randomised were included in the final analysis. ITT analysis was conducted.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasLow riskData analysis showed no significant differences between groups.

Bugmann 1998

MethodsStudy design: prospective, randomised trial.

Setting/location: hospital (Service de Chirurgie Pédiatrique, Hôpital des enfant, Geneva). Country: Switzerland.

Period of study: 1995-1996 (1 year).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: no.


ParticipantsInclusion criteria:

1. Burned paediatric patients.

2. Emergency admissions.

Exclusion criteria:

1. Patients with facial burns or associated lesions.

2. > 24 h since burn.

3. Patients treated elsewhere prior to admission.

Randomised: 76 paediatric patients (Group 1: n = 35, Group 2: n = 41).

Excluded (post-randomisation): Group 1: 5 (14.3%), Group 2: 5 (12.2%) Reasons: participants underwent tangential skin excision and skin graft.

Patients assessed: 66 (87%) Group 1: 30 (86%), Group 2: 36 (88%).

Age (years): (mean, SD): Group 1: 3.43 ± 3.7, Group 2: 3.29 ± 3.09.

Gender (male: female): Group 1: 20 (57%): 15 (43%), Group 2: 22 (54%): 19 (46%).

Burned surface (% TBSA): Group 1: 1.92% ± 2.05, Group 2: 2.29% ± 1.96.

Inhalation injury: not stated.

Time post-burn (h): < 24 h.

Burn type: Group 1: scald (hot liquid or steam) 21 (60%), contact (hot solids) 9 (26%), fire (flame) 4 (11%), electrical 1 (3%); Group 2: scald 28 (68%), contact 11 (27%), fire 2 (5%), electrical 0.

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: SSD vs silicone-coated nylon dressing.

Group 1: SSD (Flamazine, Duphar) topically every 2-3 days.
Group 2: silicone-coated nylon dressing (Mepitel; Mölnlycke, Sweden) every 2-3 days.

Duration of intervention: until complete healing.

Co-interventions: initial debridement and disinfection under sedation or general anaesthesia was performed in the same manner in the two groups. Disinfection and cleaning of the wound done with chlorhexidine.


OutcomesEpithelialization time (days).

Wound infection.

Adverse events (allergy).


NotesConflict of interest: the study was not sponsored by the manufacturer Mölnlycke.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "After written consent was obtained, we randomly assigned the patients to treatment with Mepitel (group M) or Flamazine (group F), our standard silver sulfadiazine burn dressing" (Page 609-10 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo information provided.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information provided.

Incomplete outcome data (attrition bias)
All outcomes
Low risk30/35 (86%) and 36/41 patients (88%) in the SSD and the silicone-coated nylon dressing group respectively were included in the final analysis.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasUnclear riskThe study appeared to be free of other sources of bias.

Caruso 2006

MethodsStudy design: prospective, randomised study.

Setting/location: hospital (8 burn centres - see notes for details). Country: USA.

Period of study: January 2003-September 2004 (1.8 years).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: yes. Quote: "A sample size of at least 82 patients was selected to obtain a minimum of 64 evaluable patients" (Page 301 trial report).

Use of ITT analysis?: no, Quote: "In the AQUACEL® Ag dressing group, all 42 patients were included in the safety and intent-to-treat analyses. In the silver sulfadiazine group, 40 of 42 patients were included in the safety and intent-to-treat analyses because 2 patients did not receive study treatment" (Page 301 trial report).


ParticipantsInclusion criteria:

1. Patients with burn injuries acquired within 36 h preceding enrolment.

2. Age: ≥ 2 months.

3. Partial-thickness burns, superficial burns, mid-dermal, or mixed partial-thickness burns.

4. 5%-40% TBSA

Exclusion criteria:

1. Electrical or chemical burns, or burns caused by frostbite.

2. Antibiotic taken during 2 days preceding burn injury.

3. Evidence of inhalation injury.

4. Fractures and/or neurological injury.

5. Treatment of the burn with an active agent (e.g. SSD) before study entry.

6. Pregnant.

7. Deep-partial burns or full-thickness burns (i.e. areas likely to require excision and grafting).

Randomised: 84 patients (Group 1: n = 42, Group 2: n = 42).

Excluded (post-randomisation): Group 1: 2 (5%). Reason for exclusion: these 2 patients did not receive study treatment.

Patients assessed: 82 patients (97.6%) (Group 1: n = 40 (95%) Group 2: n = 42 (100%)).

Age (years): (mean, range): Group 1: 24 (0.5-76.5), Group 2: 29.4 (0.8-80.6).

Gender (male: female): Group 1: 30 (75%): 10 (25%), Group 2: 27 (64%): 15 (36%).

Burned surface (% TBSA): (mean, range): Group 1: 10.8% (5.0-27.5%), Group 2: 12% (5.0-35.0%).

Inhalation injury: none.

Time post-burn (h): (mean, range): Group 1: 5.5 (0.0-18.7), Group 2: 7.2 (1.0-49.5).

Burn type: Group 1: scald (hot liquid or steam) 18 (45%), fire (flame) 8 (20%), contact (hot solids) 1 (2.5%), other (several agents) 13 (32.5%); Group 2: scald 27 (64.3%), fire 4 (9.5%), other 11 (26.19%).

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: SSD vs Ag dressing.

Group 1: SSD 1% cream topically once daily.
Group 2: AQUACEL® Ag dressing (ConvaTec, a Bristol-Myers Squibb company, Skillman, NJ) topically every 2-3 days.

Duration of intervention: 21 days, or until complete re-epithelialization.

Co-interventions: not stated.


OutcomesRate of full re-epithelialization (healing was defined as either 100% re-epithelialization, or within 21 days).

Time to complete wound healing (days).

Adverse event (defined as any untoward medical occurrence that was new, or worsened during the study).

Infection.

Wound infection.

Mortality.


NotesSources of support: Quote: "This study was supported by a grant from ConvaTec, a Bristol- Myers Squibb company" (Page 298). "Study centers were compensated for performing the study, and ConvaTec provided AQUACEL® Ag dressing and SSD. Patients were not compensated for their participation. ConvaTec supervised the design of the study, the data analyses, and the development of the manuscript" (Page 309 trial report).

Note on Methods section (above): Arizona Burn Center, Phoenix, Arizona; Lehigh Valley Hospital, Allentown, Pennsylvania; Hennepin County Medical Center, Minneapolis, Minnesota; Shriners Burns Hospital-Galveston, Galveston, Texas; University of South Alabama Medical Center, Mobile, Alabama; Integris Baptist Medical Center, Oklahoma City, Oklahoma; Los Angeles County and University of Southern California Medical Center, Los Angeles, California; New York-Presbyterian Hospital, New York.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Patients were assigned randomly to a protocol of care that included either AQUACEL® Ag dressing or silver sulfadiazine. The randomisation schedule was stratified by extent of burns (5% to 20% or > 20% to 40% of TBSA) and age (0–3 years or 4 years and older)" (Page 299 trial report).

Quote: "Baseline characteristics were comparable between treatment groups ( Table 1)" (Page 301 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
High riskQuote: "Study treatment was not blinded" (Page 299 trial report).

Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding.

Incomplete outcome data (attrition bias)
All outcomes
Low risk42/42 (100%) and 40/42 patients (95%) in the AQUACEL Ag dressing and in the SSD group, respectively, were included in the final analysis. Although a per protocol analysis was performed (2 participants from the SSD group were excluded due to not having received study treatment), it probably did not bias the results of the study.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasUnclear riskInsufficient information to assess whether an important risk of bias existed.

De La Cal 2005

MethodsStudy design: prospective, randomised, double blind, placebo-controlled trial.

Setting/location: hospital (burn ICU of a tertiary hospital, Getafe). Country: Spain.

Period of study: 1 May 1997-31 January 2000 (2.6 years).

Unit of randomisation: patient.

Unit of analysis: patient, event.

Sample size calculation: yes.

Use of ITT analysis?: yes. Quote:"The analysis was considered to be by intention to treat because all 10 excluded patients did not fulfil the inclusion criteria of the trial" (Page 426 trial report).


ParticipantsInclusion criteria:

1. Age: ≥ 14 years.

2. Burns of ≥ 20% TBSA.

3. Suspected, or evidence of, inhalation injury.

4. Interval between injury and admission to burn ICU ≤ 3 days.

Exclusion criteria:

1. < 3 day stay in burn ICU.

2. Withdrawal of treatment within 3 days.  

3. Immunosuppression or pregnancy.

4. Inhalation injury not requiring mechanical ventilation within first 3 days.

Randomised: 117 patients (Intervention group: n = 58, Control group: n = 59).

Excluded (post-randomisation): 10 (8.5%) (Intervention group: 5 (8.6%), Control group: 5 (8.5%)).

Reason for exclusion:

Age < 14 years: 1 (Control group); length of stay < 72 h (Intervention group: 5, Control group: 3); treatment withdrawal: 1 (Control group).

Withdrawals: Control group: 1 (0,85%). Reasons: treatment was withdrawn.

Patients assessed: 107 (91.4%) (Intervention group: 53 (91.4%), Control group: 54 (91.5%)).

Age (years): (mean, SD): Intervention group: 41.4 ± 17.7, Control group: 48.1 ± 18.5.

Gender (male: female): Intervention group: 44 (83%): 9 (17%), Control group: 40 (74%): 14 (26%).

Burned surface (% TBSA): (mean, SD): Intervention group: 34.0% ± 21.4, Control group: 37.7% ± 21.1.

TBSA full thickness burns: (mean, SD): Intervention group:19.3 ± 15.3, Control group: 19.0 ± 18.8.

Inhalation injury: Intervention group: 34 (64%), Control group: 37 (68%).

Ventilator support: Intervention group: 39 (74%), Control group: 43 (80%).

Time post-burn: ≤ 3 days (in both groups).

Burn type: not stated.

Wounds infected at baseline?: no.

Co-morbidity: not stated.


InterventionsType of antibiotic prophylaxis: non-absorbable antibiotic prophylaxis (selective digestive decontamination).

Type of interventions: selective digestive decontamination (SDD) and cefotaxime vs placebo.

Intervention group: (1) 100 mg polymyxin E, 100 mg tobramycin, and 500 mg amphotericin B given by digestive tract, 4 times/day; (2) cefotaxime 1 g iv 8-hourly for 4 days; (3) non absorbable polymyxin E, tobramycin and amphotericin B 0.5 g of a 2% paste, topical application in the oropharynx 4 times/day.

Control group: (1) placebo solution, given via digestive tract; (2) placebo solution, isotonic 0.9% saline iv; (3) placebo paste, topical application in the oropharynx.

Duration of intervention: total duration of treatment in the burn ICU.

Other co-interventions: . Enteral nutrition: all patients received a diet supplemented with ω-3-acids, nucleotides and arginine, (Perative, Abbott). Protein support was between 1.5-2.0 g/kg/d. Burn wounds were treated with closed dressings and daily application of SSD or iodine-povidone ointment. Systemic antibiotics, such as vancomycin, ceftazidime and aminoglycoside, were administered empirically when clinical signs of infection developed and were adjusted according to the microbiologic results.


OutcomesMortality.

Endogenous pneumonia (defined as the presence of new (or progressive) pulmonary infiltrates persisting for more than 48 h on chest X-ray, in addition to at least 2 of the following criteria: (1) fever ≥ 38.5°C or hypothermia < 35.0°C; (2) leukocytosis 10,000/mm or leukopenia 3000/mm; (3) isolation of potential pathogens in high concentration of ≥4+ [107 colony forming units/ml] using semi-quantitative culture, from unprotected purulent tracheal aspirates).

UTI.

Bloodstream infections (bacteraemia).

Burn wound infection.


NotesSources of support: Quote: "This study has been partially supported by two grants from Fondo de Investigación Sanitaria: FIS 02/1883 and Respira C 03/11" (Page 424 trial report).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "The patients were stratified according to the suspicion of inhalation injury" (Page 425 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Low riskCentral allocation at pharmacy, Quote: "The result of randomisation was introduced in a sealed envelope that was kept in the Department of Pharmacy" (Page 425 trial report).

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "Both control and test medication was prepared in the Department of Pharmacy of the hospital . . . The hospital pharmacist was the only person to be informed about the identity of the study medication" (Page 425 trial report).

Comment: participants and personnel were probably blinded.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "Both control and test medication was prepared in the Department of Pharmacy of the hospital . . . The hospital pharmacist was the only person to be informed about the identity of the study medication" (Page 425).

Comment: the outcome assessor was probably blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskQuote: "The analysis was considered to be by intention to treat because all 10 excluded patients did not fulfil the inclusion criteria of the trial" (Page 426 trial report).

Comment: 53/58 (91.3%) and 54/59 patients (91.5%) in the intervention and in the placebo group, respectively, were included in the final analysis.

Selective reporting (reporting bias)Low riskNo protocol provided, but the published report includes all expected outcomes.

Other biasLow riskThe 2 groups were similar with respect to sex, age, total burn area, full-thickness burn area, and inhalation injury.

Demling 1999

MethodsStudy design: randomised, prospective study.

Setting/location: hospital (Trauma and Burn Center, Brigham and Women's Hospital, Boston). Country: USA.

Period of study: not stated (published in 1999).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: yes.


ParticipantsInclusion criteria:

1. Age: ≥ 18 years.

2. Partial-thickness burns of the face (mid-dermal).

3. Burns < 50% of the facial surface.

4. Burns produced by flash flames or flame exposure.

Exclusion criteria: not stated.

Randomised: 21 patients (Group 1: n = 11, Group 2: n = 10).

Withdrawals: not stated.

Age (years): (mean, SD): Group 1: 34.5 ± 7.5, Group 2: 37.5 ± 9.

Burned surface (% TBSA): (mean, SD): Group 1: 18.5% ± 5, Group 2: 21% ± 6.

Inhalation injury: not stated.

Time post-burn (h): not stated.

Burn type: Group 1: fire (flame) 28 (48%); Group 2: fire 29 (54%).

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: bacitracin or SSD vs skin substitute.

Group 1: bacitracin ointment (mid-dermal areas) or SSD (deeper areas), topical 2 to 3 times a day.
Group 2: skin substitute coated with fibronectin (TransCyte, Advanced Tissue Sciences, La Jolla, CA).

Duration of intervention: until re-epithelialization.

Co-interventions: cleaning dermal surface before treatment. All patients underwent complete debridement of non-viable epidermis and upper dermis using blunt debridement (moist gauze) using systemic and topical analgesia. No tangential excision was performed.


OutcomesHealing time (defined as ≥ 90% re-epithelialization).

Wound infection (diagnosed if local wound demonstrated increased exudate and surrounding cellulitis).

LOS.


NotesSources of support: supported in part by The Heather Foundation.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Once categorized into major and minor burns, patients were randomised into one of the treatment modalities" (Page 257 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants and key study personnel not reported but probably not done due to the different nature of the interventions evaluated (ointment versus skin substitute).

Blinding of outcome assessment (detection bias)
All outcomes
High riskBlinding of outcome assessment not reported but probably not done due to the different nature of the interventions evaluated (ointment versus skin substitute).

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDid not report number of withdrawals.

Comment: denominator values suggested complete follow-up.

Selective reporting (reporting bias)Low riskStudy protocol was not available, but it was clear that the published reports include all expected outcomes.

Other biasUnclear riskInsufficient information to assess whether an important risk of bias existed.

Demling 2003

MethodsStudy design: randomised clinical trial.

Setting/location: hospital. Country: not stated.

Period of study: 1999-2001 (2 years).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: yes.


ParticipantsInclusion criteria:

1. Adult patients.

2. Partial-thickness burns.

3. Burns ≥ 50% of surface area of the foot.

4. Burns ≥ 10% of TBSA.

Exclusion criteria: not stated.

Randomised: 44 patients: Group 1: n = 20 (13 = 1 foot, 7 = both feet); Group 2: n = 24 (16 = 1 foot, 8 = both feet).

Withdrawals: not stated.

Age (years): (mean, SD):

Group 1: 1 foot: 39 ± 8, both feet: 29 ± 10;

Group 2: 1 foot: 41 ± 9, both feet: 32 ± 11.

Burned surface (% TBSA): (mean, SD):

Group 1: 1 foot: 3% ± 2, both feet: 5% ± 3;

Group 2: 1 foot: 3% ± 1, both feet: 6% ± 2.

Inhalation injury: not stated.

Time post-burn (h): not stated.

Burn type: scald (hot liquid or steam) 26 (60%), chemical 9 (20%), other (several agents) 9 (20%).

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: bacitracin vs skin substitute.

Group 1: bacitracin ointment, xeroform gauze, and a soft gauze topical dressing daily.
Group 2: skin substitute (TransCyte® Smith & Nephew, Inc. Largo, Florida).

Duration of intervention: until healed.

Co-interventions: after initial assessment, wounds were debrided of necrotic debris. Narcotics and nonsteroidal analgesics were used before, during, and after dressing changes.


OutcomesTime to re-epithelialization (95% of total).

Burn wound infection (defined using a quantitative swab culture method).


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "After initial assessment . . . wounds were debrided of necrotic debris and dirt then randomised into the standard of care, which included bacitracin ointment . . . or placement of the skin substitute TransCyte® . . ." (Page 2/3 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants and key study personnel not reported, but probably not done due to the different nature of the interventions evaluated (ointment versus skin substitute).

Blinding of outcome assessment (detection bias)
All outcomes
High riskBlinding of outcome assessment not reported, but probably not done due to the different nature of the interventions evaluated (ointment versus skin substitute).

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDid not report number of withdrawals.

Comment: denominator values suggested complete follow- up.

Selective reporting (reporting bias)Low riskNo protocol provided, but, given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasLow riskThe study appeared to be free of other sources of bias.

Desai 1991

MethodsStudy design: randomised clinical trial.

Setting/location: hospital (Shriners Burns Institute Galveston and the University of Texas). Country: USA.

Period of study: not stated (published in 1991).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: yes.


ParticipantsInclusion criteria:

1. Age: ≥ 5 years (able to respond to tactile stimulation and to communicate feelings of discomfort verbally).

2. Patients with burns resulting from traffic accidents.

3. Admitted within 72 h of burn injury.

Exclusion criteria: not stated.

Randomised: 15 patients (Group 1: n = 7, Group 2: n = 8).

Patients assessed: 15 (100%).

Withdrawals: not stated.

Age (years): (mean): Group 1: 11.4 ± 1.2, Group 2: 9.5 ± 1.6.

Burned surface (% TBSA): (mean): Group 1: 35% ± 7, Group 2: 50% ± 6.

TBSA full thickness burns: (mean): Group 1: 20% ± 9, Group 2: 32% ± 7.

Inhalation injury: not stated.

Ventilator support: not stated.

Time post-burn (h): ≤ 72 h.

Burn type: Group 1: fire (flame) 100%, Group 2: fire 100%.

Wounds infected at baseline?: no.

Co-morbidity: not stated.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: gentamicin iontophoresis vs routine care.

Group 1: gentamicin 1% cream (tube 30 g) layered over the ear, which was covered with the iontophoresis (treatment electrode) for 15-20 minutes, 2 times/day.
Group 2: routine care (6-hourly ear cleaning and dressing changes).

Duration of intervention: until final closure of the ear wound.

Co-interventions: all patients bathed once a day and had their ears cleaned and dressed with mafenide acetate cream 6-hourly.


OutcomesWound infection (defined as chondritis, destruction of unburned cartilage, and ear deformities).

Resistant organisms (qualitative cultures, quantitative cultures).

LOS (days).


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Subjects were randomly assigned to receive gentamicin iontophoresis . . . or to receive routine care alone" (Page 522 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants and study personnel not reported, but probably not done due to the different nature of the interventions evaluated (cream given by iontophoresis versus routine care).

Blinding of outcome assessment (detection bias)
All outcomes
High riskBlinding of outcome assessment not reported, but probably not done due to the different nature of the interventions evaluated (cream given by iontophoresis versus routine care).

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDid not report number of withdrawals.

Comment: denominator values suggested complete follow-up.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasUnclear riskInsufficient information to assess whether an important risk of bias existed.

Durtschi 1982

MethodsStudy design: prospective, randomised, double-blind clinical trial.

Setting/location: hospital (Regional Burn Center at the University of Washington). Country: USA.

Period of study: 1 September 1978-1 February 1980 (17 months).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: no.


ParticipantsInclusion criteria:

1. Age: ≥ 18 years.

2. Burns ≥ 20% TBSA.

3. All patients hospitalised in Regional Burn Center, University of Washington.

Exclusion criteria:

1. Electrical burns.

2. Admission > 48 h after burn injury.

3. Allergy to penicillin.

4. Received antibiotics in previous 30 days.

5. Infection, or suspected infection, of the burn at admission.

6. If burn previously treated with biological dressings.

7. Insulin-dependent diabetes, a disease requiring steroids or immunosuppressive therapy, massive obesity, severe malnutrition, or malignant disease

Randomised: 97 patients.

Excluded (post-randomisation): 46 (47.4%) (reported as withdrawn).

Reason for exclusion:

Patient discharged before completion of 5-day course of penicillin or placebo.

Additional antibiotics begun for undocumented reason.

Inappropriate entry into the study.

Additional antibiotics given before excision and grafting.

Patients assessed: 51 (52.6%) (Intervention group: 25 (25.7%), Control group: 26 (26.8%)).

Age (years): (mean, range): Intervention group: 31.1 (18-77), Control group: 36.8 (18-66).

Gender (male: female): Intervention group: 20 (80%): 5 (20%), Control group: 24 (92%): 2 (8%).

Burned surface (% TBSA): (mean, range): Intervention group: 14.9% (1-70%), Control group: 20% (1-91%)

TBSA full thickness burns: (mean, SD): not stated.

Inhalation injury: not stated.

Time post-burn (h): ≤ 48 h.

Burn type: Intervention group: thermal (100%), Control group: thermal (100%).

Wounds infected at baseline?: no.

Co-morbidity: not reported.


InterventionsType of antibiotic prophylaxis: systemic antibiotic prophylaxis (general).

Type of interventions: penicillin vs placebo.

Intervention group: penicillin V potassium (250 mg), orally 6-hourly for 5 days, or aqueous penicillin 1.2 million units iv 12-hourly for 5 days.

Control group: oral administration of placebo 6-hourly for 5 days.

The majority received medication or placebo by the oral route.

Duration of intervention: 5 days.

Co-interventions: wound cleansing (2 times/day) and topical application of SSD. Patients received no additional antibiotics during initial 5 days of study period. Early tangential excision and grafting were performed when deemed appropriate by attending physician. All patients received clinical care according to the standards of the Burn Center.


OutcomesBurn wound sepsis: syndrome resulting from presence of > 100,000 organisms/g biopsied wound tissue, associated with variable temperature and leucocyte count, blood chemistry abnormalities, and occasionally accompanied by positive blood cultures.

Cellulitis: an area of warm, spreading, cutaneous erythema, accompanied by local pain and fever.

Documented infection in lungs or urinary tract.

LOS (days).


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "After obtaining informed consent, patients were randomised to receive either penicillin or an identical-appearing placebo" (Page 12 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: " . . . penicillin or an identical-appearing placebo beginning on the day of admission" (Page 12 trial report).

Comment: blinding of participants and personnel probably done.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "Because the diagnosis of cellulitis is primarily based on clinical criteria, a placebo group was essential for the study design. The physicians responsible for diagnosing cellulitis knew only that a patient was receiving either penicillin or placebo, but were unaware of the patient assortment".

Comment: blinding of outcome assessment probably done.

Incomplete outcome data (attrition bias)
All outcomes
High riskOnly 51/97 randomised patients included in the analysis.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasUnclear riskInsufficient information to assess whether an important risk of bias existed.

Fisher 1968

MethodsStudy design: randomised clinical trial.

Setting/location: hospital (Red Cross War Memorial Children's Hospital). Country: South Africa.

Period of study: not stated (published in 1968).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: yes.


ParticipantsInclusion criteria:

1. Age: ≤ 12 years.

2. Burns ≥ 5% TBSA.

3. Burns sustained up to 10 h before admission.

Exclusion criteria: not described.

Randomised: 99 children (Group 1: n = 33, Group 2: n = 33, Group 3: n = 33).

Burned surface (% TBSA): 22 patients < 10% TBSA burn, 10 patients 10-20% TBSA burn, 1 patient > 20% TBSA burn (same percentages for each group).

Inhalation injury: not described.

Time post-burn (h): ≤ 10 h.

Burn type: Group 1: scald (hot liquid or steam) 30 (91%), fire (flame) 3 (9%); Group 2: scald 30 (91%), fire 3 (9%); Group 3: scald 30 (91%), fire 3 (9%).

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: polybactrin vs Dermoplast vs control.

Group 1: polybactrin spray (mixture of zinc bacitracin, neomycin and polymyxin B), administered topically.
Group 2: Dermoplast spray (benzocaine 4.5%, benzethonium chloride1.1%, menthol 0.5%, methyl paraben 2% and 8-hydroxyquinoline 0.83 %), administered topically.

Group 3: (Control): no spray.

Sprays applied in 5-second bursts 24 inches (61 cm) from the burn, 4-hourly throughout exposure treatment.

Duration of intervention: until final healing of burn wound.

Co-interventions: morphine 1.0 mg/12 lb (5.44 kg) body-weight, or pethidine 0.5 mg/lb (0.45 kg) body-weight, was given on admission, with further doses as necessary. No excision or debridement of burn surface done, home remedies not removed and blisters not opened. If infection supervened, instituted closed treatment with framycetin sulphate antibiotic cream. Systemic antibiotics administered only in presence of systemic illness or if beta-haemolytic streptococcus was isolated. After preparation by regular dressing changes, deep burns were grafted as soon as possible, usually between days 17-25, using large sheets of split-thickness skin placed edge to edge.


OutcomesInfection (bacteraemia, sepsis).

Wound infection (bacterial culture swabs).

Healing time (days).


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "To meet the likelihood that inherent differences in the size and depth of burns would cause sufficient variation in healing to conceal differences between treatments, a random block' experimental design was utilized . . . After assignment to a block, treatment was randomly allocated . . . " (Page 903 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "A sealed box at each patient's bedside contained the appropriate spray, or none, and medical staff responsible for clinical management were unaware of the local treatment" (Page 903 trial report).

Comment: participants and personnel were probably blinded.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information provided.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDid not report number of withdrawals.

Comment: denominator values suggested that all patients who were randomised were included in the final analysis.

Selective reporting (reporting bias)High riskThe study protocol was not available and the methods section did not pre-specify outcomes to be reported.

Other biasLow riskQuote: "In this study the problem of such bias was met by means of a blind trial, while a random block experimental design has permitted analysis of the effects of treatment over a wide range of burn size and severity. Significant differences between blocks in the time required for healing have been found, vindicating this method of analysis" (Page 904 trial report).

Gerding 1988

MethodsStudy design: randomised prospective study.

Setting/location: hospital (Burn Center, Cleveland Metropolitan General Hospital, Cleveland). Country: USA.

Period of study: not stated (published in 1988).

Unit of randomisation: burn wound.

Unit of analysis: burn wound.

Sample size calculation: no.

Use of ITT analysis?: unclear.


ParticipantsInclusion criteria:

1. Patients admitted to the Burn Center.

2. Age: > 2 months.

3. Acute partial-thickness burns (with a moist, sensate surface and prompt capillary refill).

4. Thermal burns.

Exclusion criteria:

1. Grossly contaminated wounds.

2. Wounds > 6 h old.

3. Wounds previously treated by topical creams or other agents before admission.

4. Chemical and electrical burns.

Randomised: 50 partial-thickness burns (in 43 patients) (Group 1: n = 27, Group 2: n = 23) (paired controls).

Excluded (before randomisation): 4 patients (8%). Reason for exclusion: 1 died of puImonary embolism, 1 transferred to a home-state hospital before completion of protocol, 1 due to protocol violation, and 1 because of skin infection which antedated the burn wound.

Assessed: 50 burn wounds (100%).

Withdrawals: not stated.

Age (years): (mean, range): Group 1: 17.6 (6 months-71), Group 2: 22 (6 months-71).

Gender (male: female): 34 (79%): 9 (21%).

Burned surface (% TBSA): (mean ± SEM, range): Group 1: 6.1% ± 0.9 (1.5-26%), Group 2: 6.5% ± 0.1 (1.5-12%).

Inhalation injury: not stated.

Time post-burn (h): < 6 h.

Burn type: scald (hot liquid or steam) 29 (67%), fire (flame) 12 (28%), contact (hot solids) 2 (5%).

Wounds infected at baseline?: no.

Co-morbidity: not stated.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: biosynthetic skin dressing vs SSD.

Group 1: biosynthetic dressing (Biobrane, Woodroof Laboratories, Winthrop, Santa Ana, CA), daily application.
Group 2: SSD 1% cream (Marion Laboratories, Kansas City, MO) twice daily.

Wounds in both groups then dressed with gauze bandage and elastic outer wraps.

Duration of intervention: 21 days.

Co-interventions: initial therapy of study wounds consisted of complete debridement of blisters and loose tissue, and cleansing with sterile saline. Detergents and antiseptic solutions were not utilised.


OutcomesHealing time (days) (wounds considered healed when completely re-epithelialized).

Infection rate (wound infections diagnosed on clinical grounds in conjunction with semi-quantitative surface swab cultures).


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Randomization was achieved by computer-generated codes within sealed, numbered envelopes that were opened sequentially . . . Twenty-seven burn wounds were randomised for treatment with Biobrane (Group I) and 23 wounds (Group II) randomised for treatment with 1% silver sulfadiazine cream (Marion Laboratories, Kansas City, MO). Seven patients who presented with anatomically separate but similar burn wounds were chosen to serve as matched controls by randomising the paired wounds to treatment by opposite modalities" (Page 1265 trial report).

The 2 groups were similar with respect to sex, race, and burn agent (Table I).

Allocation concealment (selection bias)Unclear riskQuote: "Randomization was achieved by computer-generated codes within sealed, numbered envelopes that were opened sequentially" (Page 1265 trial report).

Comment: the authors did not describe whether the envelopes were opaque.

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants and key study personnel not reported, however, the study was probably not blinded (as for other similar studies by the same author (Gerding 1990)).

Blinding of outcome assessment (detection bias)
All outcomes
High riskBlinding of outcome assessors not reported, however, it was probably not blinded (as for other similar studies by the same author (Gerding 1990)).

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskIt is not clear when the exclusions occurred (before or after randomisation), so it is not possible to make a judgement about its impact in the study results.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasLow riskThe study appeared to be free of other sources of bias.

Gerding 1990

MethodsStudy design: randomised, prospective study.

Setting/location: hospital (Emergency Department and Burn Clinic of the Cleveland Metropolitan General Hospital, Cleveland). Country: USA.

Period of study: not stated (published in 1990).

Unit of randomisation: burn wound.

Unit of analysis: burn wound.

Sample size calculation: no.

Use of ITT analysis?: no.


ParticipantsInclusion criteria:

1. Age: ≥ 2 months.

2. Acute partial-thickness burns.

3. No history of sulphonamide sensitivity.

4. Wounds with moist, sensate surface and prompt capillary refill.

Exclusion criteria:

1. Chemical or electrical burns.

2. Grossly contaminated wounds.

3. Wounds > 24 h old.

4. Wounds treated by any topical agent before admission.

5. Pregnancy.

Randomised: 64 patients.

Excluded (post-randomisation): Group 1: 7 patients (21%), Group 2: 5 patients (16%). Reason for exclusion: Group 1: 4 protocol violations by non-investigators, 2 lost to follow-up, 1 found to be suffering from scarlet fever (without evidence of wound infection); Group 2: 1 had protocol violations by non-investigators, 4 lost to follow-up.

Withdrawals: Group 1: 2 patients (6%), Group 2: 4 patients (13%). Reasons: lost to follow-up.

Patients assessed: 52 patients (81%) (56 burn wounds: Group 1: 30, Group 2: 26).

Age (years): (mean ± SEM, range): Group 1: 18.3 ± 2.6 (10 months-55), Group 2: 22.1 ± 3.5 (8 months-79).

Gender (male: female): Group 1: 19 (74%): 11 (26%), Group 2: 18 (69%): 8 (31%).

Burned surface (% TBSA): (mean ± SEM, range): Group 1: 2.0% ± 0.3 (0.5-5.0), Group 2: 2.4% ± 0.5 (0.5-10.0).

Inhalation injury: not stated.

Time post-burn (h): not stated.

Burn type: aqueous scald, grease, contact, other.
Aqueous scald burns were the most common and were attributable to hot water, coffee, tea, soup, or steam.

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: biosynthetic dressing vs SSD.

Group 1: biosynthetic dressing (Biobrane).
Group 2: SSD 1% topically twice daily.

Duration of intervention: until complete healing.

Co-interventions: all study wounds were completely debrided of blisters and loose tissue and cleansed with sterile saline before randomisation. Wounds in both groups were covered with dry gauze and elastic wraps. Adult patients were given prescriptions for acetaminophen with codeine, and children were treated with acetaminophen alone. Wounds that developed eschar were treated with SSD 1% or surgically excised.


OutcomesHealing time (defined as time required to re-epithelialize the burn surface fully).

Burn wound infection (infected and skin grafted wounds were considered failures of therapy and excluded from healing time analysis).


NotesQuote: "The groups also were well matched by mechanisms of injury (Figure 1)" (Page 122 trial report).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Randomization was achieved by computer-generated codes within sealed, numbered envelopes that were opened in sequential fashion" (Page 122 trial report).

Quote: "There were no significant differences in age, race, or gender distribution between the two groups (Table)" (Page 122).

Allocation concealment (selection bias)Unclear riskQuote: "Randomization was achieved by computer-generated codes within sealed, numbered envelopes that were opened in sequential fashion" (Page 122).

Comment: the authors do not describe if the envelopes were opaque.

Blinding of participants and personnel (performance bias)
All outcomes
High riskQuote: "Although this study was randomised, it is limited by the fact that it was not blinded. Neíther the treating physicians nor those who judged healing times were or could have been blinded to the treatment type" (Page 124 trial report).

Blinding of outcome assessment (detection bias)
All outcomes
High riskQuote: "Although this study was randomised, it is limited by the fact that it was not blinded. Neíther the treating physicians nor those who judged healing times were or could have been blinded to the treatment type" (Page 124 trial report).

Incomplete outcome data (attrition bias)
All outcomes
High riskOnly 52/64 randomised patients included in the analysis.

Comment: the magnitude of losses during the study was > 20%.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasUnclear riskInsufficient information to assess whether an important risk of bias existed.

Glat 2009

MethodsStudy design: prospective, randomised study.

Setting/location: hospital (Burn Unit, St Christopher’s Hospital for Children, Pennsylvania). Country: USA.

Period of study: not stated (published in 1988).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: yes.


ParticipantsInclusion criteria:

1. Paediatric patients (2 months-18 years).

2. Partial-thickness burns (superficial and mid-dermal wounds).

3. Burn wounds acquired within previous 36 h.

4. Burns > 1% to < 40% TBSA.

5. Patients or their parents able to consent to both inclusion in the study and treatment until wounds were completely healed.

Exclusion criteria:

1. Deep burns or full-thickness burns.

2. Burn associated with electrical or chemical injury.

3. Patient not expected to survive for duration of study.

4. Burn site previously treated with an antimicrobial agent or debrided with an enzymatic agent.

5. Previous participation in a similar study.

6. Pregnancy.

Randomised: 24 patients (Group 1: n = 12, Group 2: n = 12).

Patients assessed: 24 (100%).

Age (years): (mean ± SD, range): Group 1: 43 months ± 29.10 (9 months-9 years), Group 2: 22.78 months ± 13.51, (13 months-5 years).

Burned surface (% TBSA): TBSA for the wound injury site was comparable for both study arms and ranged from 1-10%.

Inhalation injury: not stated.

Time post-burn (h): ≤ 36 h (in both groups).

Burn type: not reported.

Wounds infected at baseline?: no.

Co-morbidity: not stated.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: biocompatible hydrogel (silver ions) vs SSD.

Group 1: SilvaSorb Gel (silver ions) amorphous, biocompatible hydrogel, applied topically every 2-3 days.
Group 2: SSD cream (Silvadene) applied topically every 2-3 days.

Outpatients and/or their guardians were allowed to change their own dressing and were provided with general practice instructions by the burn centre and on the use of the treatments.

Duration of intervention: until complete healing.

Co-interventions: not stated.


OutcomesTime to full re-epithelialization (days).

Adverse events.

Wound infection.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Patients were randomly assigned to a protocol of care that included either SSD cream or SilvaSorb Gel" (Page 263 trial report).

Quote: "Baseline characteristics were comparable between the treatment and control arms of the study with the exception of patient age" (Page 264).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
High riskQuote: ". . . without blinding of the physician investigator or other medical personnel to the type of treatment" (Page 263 trial report).

Comment: participants and personnel were probably not blinded.

Blinding of outcome assessment (detection bias)
All outcomes
High riskQuote: " . . . without blinding of the physician investigator or other medical personnel to the type of treatment" (Page 263 trial report).

Comment: outcome assessors were probably not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNumber of withdrawals not reported.

Comment: denominator values suggested that all randomised patients were included in the final analysis.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasLow riskThe study appeared to be free of other sources of bias.

Gong 2009

MethodsStudy design: randomised controlled trial.

Setting/location: hospital (First People's Hospital of Nantong, Jiangsu). Country: China.

Period of study: May 2007-May 2009 (2 years).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: yes.


ParticipantsInclusion criteria:

1. Age: 20-40 years.

2. 2nd-degree burns.

3. Burns < 10% TBSA.

4. Burns thermal flame or scald (hot fluids).

5. No infection on wound surface.

Exclusion criteria:

1. Serious dysfunction of liver or serious renal dysfunction.

2. Chronic consumption.

3. Allergy to silver dressing and hydrogel.

4. Cephalofacial and cervicalis wound surface.

5. Patient and family wanted surgery.

Randomised: 104 patients (Group 1: n = 52, Group 2: n = 52).

Patients assessed: 104 (100%).

Withdrawals: none withdrew or were lost to follow-up.

Age (years): (mean, range):

Superficial degree II: Group 1: 27.3 ± 3.8, Group 2: 27.6 ± 3.4;

Deep degree II: Group 1: 29.2 ± 4.7, Group 2: 28.6 ± 3.7.

Gender (male:female): 62 (60%): 42 (40%).

Burned surface (% TBSA): (mean, range):

Superficial degree II: Group 1: 7.4 ± 1.6, Group 2: 7.1 ± 1.5;

Deep degree II: Group 1: 7.7 ± 1.4, Group 2: 7.3 ± 1.3.

Inhalation injury: not stated.

Time post-burn (h): not stated.

Burn type:

Superficial degree II: Group 1: scald (hot liquid or steam) 15 (29%), fire (flame) 13 (25%); Group 2: scald 15 (29%), fire 13 (25%);

Deep degree II: Group 1: scald 13 (25%), fire 11 (21%); Group 2: scald 12 (23%), fire 12 (23%).

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: ionic silver dressing/hydrogel vs SSD.

Group 1: ionic silver pressure dressing once daily for 7 days; then hydrogel was used.
Group 2: SSD 1% topically once daily.

Duration of intervention: 21 days.

Co-interventions: routine antiinflammatory treatment, treatment to activate blood circulation, and provision of nutritional support.


OutcomesBurn wound infection.

Wound healing time.

Adverse events.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskParticipants were allocated to interventions on the basis of a sequence generated by random-number tables.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
High riskThe trial was not blinded.

Blinding of outcome assessment (detection bias)
All outcomes
High riskThe trial was not blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing outcome data.

Denominator values suggested that all patients who were randomised were included in the final analysis.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasLow riskThe study appeared to be free of other sources of bias.

Gotschall 1998

MethodsStudy design: prospective, randomised, controlled clinical trial.

Setting/location: hospital (Children's National Medical Center, Washington). Country: USA.

Period of study: 1 November 1993-31 December 1996 (3.1 years).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: unclear.


ParticipantsInclusion criteria:

1. Age: ≤ 12 years.

2. Admitted to the regional paediatric burn centre.

3. Partial-thickness burns.

4. Scald burns (defined as burns resulting from hot non-viscous fluids and did not include substances such as oatmeal or mashed potato).

5. Burns ≤ 15% TBSA

6. When the burns affected only were flat body surfaces.

Exclusion criteria:

1. Children suspected to be victims of child abuse.

2. History of allergy to silicone.

3. Chronic diseases that might affect the healing process (e.g. white blood cell deficiency).

Randomised: 63 children (Group 1: n = 33, Group 2: n = 30).

Withdrawals: children whose wounds converted to full-thickness were withdrawn from the study.

Burned surface (% TBSA): (mean, SD):Group 1: 6.8% ± 3.4%, Group 2: 5.1% ± 2.2%.

Inhalation injury: not stated.

Time post-burn (h): not stated.

Burn type: Group 1: scald (hot liquid or steam) 33 (100%); Group 2: scald (hot liquid or steam) 30 (100%).

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: silicone mesh dressing vs SSD.

Group 1: silicon-coated nylon dressing (Mepitel, Mölnlycke Health Care, USA).
Group 2: SSD cream.

Gauzes wet and dry were applied under cotton gauze dressing over both treatment arms.

Duration of intervention: until complete healing.

Co-interventions: not stated.


OutcomesWound healing.

Healing time (measured by number of days until wounds were 25%, 50%, 75% and 100% epithelialized).

Burn wound infection (clinical data and swab culture).


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Treatment was assigned randomly" (Page 280 trial report).

Quote: "There were no significant differences between the two groups with respect to age, sex, or race" (Page 280 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
High riskIt was not reported whether participants and personnel were blinded, but they were probably not, due to the different nature of the interventions.

Blinding of outcome assessment (detection bias)
All outcomes
High riskQuote: "The principal Iimitation of this investigation is the lack of "blinding" to treatment assignment by the people assessing the wounds at the dressing changes" (Page 283 trial report).

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDid not report number of withdrawals.

Quote: ". . . children whose wounds had converted to full-thickness were withdrawn from the study" (Page 280 trial report).

Comment: it is not clear whether the outcome data were incomplete.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasLow riskThe study appeared to be free of other sources of bias.

Hauser 2007

MethodsStudy design: a randomised, controlled, intra-individual comparative study.

Setting/location: hospital. Country: Germany.

Period of study: not stated (published in 2007).

Unit of randomisation: burn wound.

Unit of analysis: burn wound.

Sample size calculation: no.

Use of ITT analysis?: yes (per protocol cohort).


ParticipantsInclusion criteria:

1. 2nd-degree burns (partial-thickness burns).

2. 2 wounds of comparable size and location (noncontiguous).

3. Wounds without clinical data suggesting infection.

4. Burns of ≤ 50% TBSA.

5. ≤ 3 h post-burn.

Exclusion criteria:

1. Drug and alcohol abuse.

2. Pregnant or breastfeeding women.

3. Contraindications to SSD or hydrosome gel.

Randomised: 47 patients (94 burn wounds).

Patients assessed: 43 (91.5%) 86 burn wounds, Group 1: 43 burn wounds, Group 2: 43 burn wounds.

Withdrawals: not stated.

Age (years): (mean, range): 37.2 (3-78).

Gender (male: female): 34 (72%): 13 (28%).

Burned surface (% TBSA): (mean): 11.1%.

Inhalation injury: not stated.

Time post-burn (h): ≤ 3 h.

Burn type: not stated.

Wounds infected at baseline?: no.

Co-morbidity: 15 patients were smokers, 31 non-smokers and former smokers.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: hydrosome gel vs SSD.

Group 1: SSD cream (Flammazine®, Solvay Arzneimittel GmbH, Hannover, Deutschland) topically once a day.

Group 2: hydrosome wound gel (Repithel®, Mundipharma GmbH, Limburg/Lahn, Deutschland) topically once a day.

Duration of intervention: until complete healing (21 days).

Co-interventions: not stated.


OutcomesTime to complete wound healing (days).

Wound infection (clinical evaluation and analysis by microbiological laboratory).


NotesConflict of interest: the research activities of Prof Steinau are funded on the basis of contracts between the BG-Kliniken Bergmannsheil Bochum and the company Mundipharma. The corresponding author argues that, despite the potential conflict of interest, they conducted the study in an independent manner.

Quote: "Interessenkonflikt. Die Forschungstätigkeit von Prof. Steinau wird auf der Grundlage von Verträgen zwischen den BG-Kliniken Bergmannsheil Bochum und der Firma Mundipharma gefördert. Der korrespondierende Autor versichert, dass trotz des möglichen Interessenkonflikts der Beitrag unabhängig und produktneutral ist" (Page 994 trial report).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskBoth wounds were randomly assigned for each treatment. Randomization was performed using the computer program "Rancode 3.6".

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
High riskQuote: "Eine Verblindung der Studie war aufgrund der präparatspezifischen Farbe des HW bedingt durch die PVP-Iod- Komponente nicht möglich" (Page 990 trial report).

Comment: blinding of participants and personnel was not possible due to the different colours of the topical interventions evaluated.

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot done, because of the different colours of the topical interventions evaluated.

Incomplete outcome data (attrition bias)
All outcomes
Low risk43/47 patients included in the final analysis; although 4 randomised participants were not included in the analysis, this probably did not bias the results of the study.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasUnclear riskInsufficient information available to assess whether an important risk of bias existed.

Hosseini 2009

MethodsStudy design: prospective, randomised clinical trial.

Setting/location: hospital (Shafieeh Hospital in Zanjan). Country: Iran.

Period of study: March 2006-November 2007 (1.8 years).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: no.


ParticipantsInclusion criteria:

1. Burns patients.

2. Partial-thickness burns (2nd-degree burns).

3. Burns 10–60% TBSA.

4. Scald or flames.

Exclusion criteria:

1. 3rd-degree burns.

2. Contact burns and others.

3. Infection.

4. Contaminated wounds (with chemical or faecal material, or soil).

5. Comorbid diseases.

6. Fractures.

7. Neurological injury.

8. Pregnancy.

Randomised: 78 patients (Group 1: n = 39, Group 2: n = 39).

Excluded (post-randomisation): Group 1: 2 (5%). Reason for exclusion: left the hospital 2 days after admission.

Patients assessed: 76 (97.4%) Group 1: 37, Group 2: 39.

Withdrawals: not stated.

Age (years): (mean, range): Group 1: 24.9 (1-67), Group 2: 18.9 (1-74).

Gender (male: female): Group 1: 24 (64.9%): 13 (35.1%), Group 2: 26 (66.7%): 13 (33.3%).

Burned surface (% TBSA): (mean, range): Group 1: 16.4% (10-54%), Group 2: 17.6% (10-45%).

TBSA full thickness burns: Group 1: 9 (24.3%), Group 2: 12 (30.8%).

Inhalation injury: Group 1: 6 (16.2%), Group 2: 11 (28.2%).

Time post-burn: participants admitted on day on which they were burned: Group 1: 30 (81.1%), Group 2: 37 (94.9%).

Burn type: Group 1: scald (hot liquid or steam) 15 (40.5%), fire (flame) 22 (59.5%); Group 2: scald 20 (51.3%), fire 19 (48.7%).

Wounds infected at baseline?: no.

Co-morbidity: no comorbidity.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: SSD vs skin substitute.

Group 1: SSD 1% daily topical application, and the wound was treated daily with washing and cleaning.

Group 2: lyophilised porcine skin (Xenoderm, Medical Biomaterial Products, Berlin, Germany).

After tangential excision or dermabrasion of the burned area with a dermatome, and rinsing the wound with normal saline, Xenoderm was placed on the wound by the surgeon and fixed in place using a suture, dressing, or bandage.

Duration of intervention: 2-5 weeks.

Co-interventions: In the Xenoderm group, all patients received cefazolin during the surgery (tangential escisión or dermabrasion), before the application of Xenoderm. The burned region was immobilised by a splint if necessary.


OutcomesWound infection (secretion of pus).

Length of hospital stay (days).


NotesSources of support: quote. "This study was supported by a grant from the Deputy for Research of Zanjan University of Medical Sciences" (Page 239 trial report).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "The patients were randomly divided into two groups consecutively" (Page 235 trial report).

Quote: "There were no significant differences between the two groups with respect to age, gender, % TBSA, cause of burn, burn thickness or burn site ( Table 1)" (Page 236 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
High riskIt was not reported whether participants and personnel were blinded, but they were probably not, because of the different nature of the interventions (topical SSD vs porcine skin).

Blinding of outcome assessment (detection bias)
All outcomes
High riskIt was not reported whether outcome assessors were blinded, but they were probably not, because of the different nature of the interventions (topical SSD vs porcine skin).

Incomplete outcome data (attrition bias)
All outcomes
Low risk37/39 (95 %) and 39/39 patients (100%) in the SSD and lyophilised porcine skin groups, respectively, were included in the final analysis.

Selective reporting (reporting bias)Low riskNo protocol was provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasLow riskThe study appeared to be free of other sources of bias.

Khorasani 2009

MethodsStudy design: randomised controlled study.

Setting/location: hospital (Zare’s Burn Hospital, Sari). Country: Iran.

Period of study: not stated (published in 2009).

Unit of randomisation: site burn.

Unit of analysis: site burn.

Sample size calculation: no.

Use of ITT analysis?: yes.


ParticipantsInclusion criteria:

1. Burns acquired within 24 h preceding initiation of treatment.

2. 2 same site burns (such as on the feet or hands) on each participant.

3. Partial-thickness burns (2nd-degree burns with respect to depth and similar surface areas in 2 different parts of the body).

4. Burns ≤ 40% TBSA.

Exclusion criteria:

1. Diabetes.

2. Immunodeficiency.

3. Pregnancy.

4. Kidney diseases.

5. Electrical and chemical burns.

Randomised: 30 patients (60 burn wounds: Group 1: n = 30, Group 2: n = 30).

Age (years): (mean, SD): 33 ±11.

Gender (male: female): 25 (83%): 5 (17%).

Burned surface (% TBSA): (mean, SD, range): 19.8 ± 7.9 (10-40).

Inhalation injury: not stated.

Time post-burn (h): < 1 h: 15 patients (50%); 1-3 h: 12 patients (40%); > 3 h: 3 patients (10%).

Burn type: not stated.

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: SSD vs Aloe vera.

Group 1: SSD topically twice daily.
Group 2: Aloe vera cream (Aloe vera powder (Zarband Phytopharmaceutical, Tehran, Iran), white paraffin 2 g, sterile alcohol 7.5 g, cetyl alcohol 7.5 g, solid white paraffin 3 g, and propylene paraben 0.015 g) topically twice daily.

Duration of intervention: until burns were fully healed and epithelialized.

Co-interventions: all patients were treated with fluid resuscitation, daily dressings, and other treatment protocols during their hospitalisation. After admission, the wounds were cleaned with water or normal saline solution and the topical agent. All patients were given oral nutrition with occasional iv support in the form of amino acid infusion and blood products during their hospital stay.


OutcomesBurn wound infection (wound observed clinically for signs of infection).

Healing time.


NotesSources of support: quote: "This work was supported by a grant from Mazandaran University of Medical Sciences, Sari, Iran" (Page 590 trial report).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo information provided.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "Patients and nursing staff were blinded to the procedure" (Page 588 trial report).

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information provided to permit a judgement to be made.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDid not report number of withdrawals.

Comment: denominator values suggested complete follow- up

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasUnclear riskInsufficient information provided to assess whether an important risk of bias existed.

Kimura 1998

MethodsStudy design: prospective, randomised, placebo controlled study.

Setting/location: hospital (Emergency and Critical Care Center of Nippon Medical School Hospital). Country: Japan.

Period of study: April 1994-September 1996 (2.4 years).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: yes.


ParticipantsInclusion criteria:

1. Age: ≥ 10 years.

2. Burns of ≥ 20% TBSA.

3. Requirement for ventilator support.

Exclusion criteria:

1. Children (< 10 years old).

2. Pregnant women.

3. Patients with severe underlying diseases such as renal failure, hepatic failure, and leukopenia.

Randomised: 40 participants (Intervention group: n = 21, Control group: n = 19).

Age (years): (mean, range): Intervention group: 44 (10-91), Control group: 48 (12-85).

Burned surface (% TBSA): (mean, range): Intervention group: 49% (22-87%), Control group: 43% (20-80%).

Inhalation injury: Intervention group: 11 (52.4%), Control group: 12 (63.2%).

Ventilator support: Intervention group: 21 (100%), Control group: 19 (100%).

Time post-burn (days): 4-6 days.

Burn type: Intervention group: fire (flame) 19 (90%), scald (hot liquid or steam) 2 (10%); Control group: fire 16 (84%), scald 3 (16%).

Wounds infected at baseline?: no.

Co-morbidity: none.


InterventionsType of antibiotic prophylaxis: systemic antibiotic prophylaxis (general).

Type of interventions: TMP-SMX vs placebo.

Intervention group: TMP-SMX (1.0 g) containing 400 mg SMX and 80 mg TMP.
Control group: placebo (lactose 1.0 g).

Both TMP-SMX and placebo were administered orally or by means of a nasogastric tube 3 times daily.

Other antibacterial therapies (ampicillin; cefazolin; cefamandole; cefmetazole; flomoxef) were used with TMP-SMX or placebo when deemed necessary by the treating physicians.

Duration of intervention: 10 days.

Co-interventions: not described.


OutcomesIncidence of pneumonia (defined when all the following criteria present: (1) infiltration of lung fields on chest X-ray films, (2) fever (> 38°C) for at least 3 consecutive days, (3) peripheral white blood cell count > 104/mm3, (4) pathogenic bacteria (> 103 colony forming units/ml) detected in airway secretions).

Incidence of MRSA pneumonia.

Mortality.

Airway flora.

Side effects.


NotesSources of support: Quote: "We are indebted to MI. Yasuji Aoto, laboratory technician at Nippon Medieal Sehool Hospital, for collecting bacterial strains, and Shionogi Pharmaceutical Company for technical assistance in measuring TMP-SMX concentrations" (Page 386).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "The subjects were divided into TMP-SMX and placebo groups in a randomised manner by the attending pharmacist" (Page 384 trial report).

Comment: insufficient information provided to permit a judgement to be made.

Allocation concealment (selection bias)Low riskCentral pharmacy.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: " . . with both the patient and the attending physician being blinded to the treatment protocol" (Page 384 trial report).

Comment: participants and personnel were probably blinded.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskIt was not reported whether the outcome assessors were blinded (but they probably were, if the attending physician was the person who assessed the outcomes).

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDid not report number of withdrawals

Comment: denominator values suggested that all patients randomised were included in the final analysis.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasLow riskThe study appeared to be free of other sources of bias.

Levine 1978

MethodsStudy design: prospective, randomised trial.

Setting/location: hospital (US Army Institute of Surgical Research, Houston, Texas). Country: USA.

Period of study: not stated (published in 1978).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: yes.


ParticipantsInclusion criteria:

1. Age: ≥ 16 years.

2. Suspected, or evidence of, inhalation injury (with positive bronchoscopic findings of carbonaceous material, or of tracheobronchial mucosal edema, erythema, haemorrhage, or ulceration).

3. Patient admitted within 72 h of acquiring burn injury.

Exclusion criteria: not described.

Randomised: 30 patients (Intervention group: n = 12, Control group: n = 18).

Age (years): (mean): Intervention group: 34.3, Control group: 28.1.

Burned surface (% TBSA): (mean): Intervention group: 57.6%, Control group: 53.8%.

Inhalation injury: Intervention group: 12 (100%), Control group: 18 (100%).

Time post-burn (h): ≤ 72 h (in both groups).

Burn type: Intervention group: thermal (100%), Control group: thermal (100%).

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: local antibiotic prophylaxis (airway).

Type of interventions: gentamicin vs placebo.

Intervention group: aerosolized gentamicin, 80 mg in 2 ml of diluent.
Control group: placebo (2 ml of aerosolized normal saline).

Both groups received treatment 3 times daily, administered by airway.

Duration of intervention: 10 days.

Co-interventions: All burn wounds were cleaned and debrided at time of admission and treated with either SSD (Silvadene) or mafenide acetate (Sulfamylon) creams. Escharotomies were performed only as necessary on all circumferentially burned extremities and the thorax. All patients in both trials were resuscitated over the first 24 h with Ringer's lactate solution. Humidified oxygen was given by face mask. Endotracheal intubation with controlled mechanical ventilation was instituted on the basis of recognized criteria (hypoxia, hypercarbia, and markedly increased respiratory rate).


OutcomesMortality.

Sepsis.

Pulmonary complications attributable to inhalation injury (e.g. pneumonitis, bronchitis, severe atelectasis, and lobar collapse)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Thirty patients with proven inhalation injuries were allocated in a prospective randomised manner into either a gentamicin or placebo-treated group" (Page 189 trial report).

Comment: insufficient information provided to permit a judgement to be made

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo information provided.

Placebo inhalations used, so likely that participants and personnel were blinded.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information provided.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDid not report number of withdrawals.

Comment: denominator values suggested that all patients randomised were included in the final analysis.

Selective reporting (reporting bias)High riskThe study protocol was not available, and the methods section did not pre-specify the outcomes to be reported.

Other biasUnclear riskInsufficient information to assess whether an important risk of bias existed.

Livingston 1990

MethodsStudy design: prospective randomised study.

Setting/location: hospital (Adult Burn Unit, University of Louisville, Kentucky). Country: USA.

Period of study: January 1987-January 1988 (12 months).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: no.


ParticipantsInclusion criteria:

1. Patients admitted to the Adult Burn Unit.

2. Thermal burns requiring skin grafting.

Exclusion criteria:

1. Use of non-meshed grafts (hand and face grafts).

2. Allergy to any of the test agents (neomycin, bacitracin, silver nitrate).

Enrolled: 90 patients.

Randomised: unclear.

Active participants: 52 patients (57.7%) (Group 1: n = 15, Group 2: n = 18 , Group 3: n = 19).

Withdrawals: not described.

Patients assessed: 52 patients.

Age (years): (mean):

Group 1: < 20% TBSA: 46 ± 22, 20-40% TBSA: 27 ± 5, > 40% TBSA: 49 ± 10.

Group 2: < 20% TBSA: 48 ± 24, 20-40% TBSA: 38 ± 22, > 40% TBSA: 52 ± 13.

Group 3: < 20% TBSA: 43 ± 27, 20-40% TBSA: 34 ± 20, > 40% TBSA: 43 ± 19.

Burned surface (% TBSA): (mean):

Group 1: < 20% TBSA: 14% ± 5, 20-40% TBSA: 29% ± 7, >40% TBSA: 47% ± 6.

Group 2: < 20% TBSA: 11% ± 3, 20-40% TBSA: 28% ± 6, >40% TBSA: 53% ± 16.

Group 3: < 20% TBSA: 13% ± 5, 20-40% TBSA: 30% ± 6, >40% TBSA: 52% ± 11.

Inhalation injury: Group 1: 5 (33.3%), Group 2: 4 (22.2%), Group 3: 2 (10.5%).

Time post-burn: not stated.

Burn type: Group 1: thermal (100%), Group 2: thermal (100%), Group 3: thermal (100%).

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: placebo vs neomycin plus bacitracin vs silver nitrate.

Group 1: placebo (Ringer's lactate (RL)).

Group 2: neomycin (1 g/litre) plus bacitracin (50,000 units/litre) (NB).

Group 3: silver nitrate 0.5% (Ag).

The solutions were applied topically with gauze soaked in the operating room. The solutions were reapplied as necessary to keep the grafted areas moist (every 2-6 h).

Duration of intervention: until grafts were healed, or there was evidence of graft loss or infection.

Co-interventions: patients received standardized resuscitation with Ringer's lactate solution. Enteral or parenteral nutrition was started as soon as the patient could tolerate it, and full nutritional support was applied 5 days postburn. All patients received cefazolin perioperatively (during excision and grafting, ̄before randomization). Escharotomies were performed when clinically indicated in patients with circumferential burns. The catheters (arterial, central venous, pulmonary artery) were placed when clinically indicated. Tangential excision and split-thickness skin grafting were performed as soon as the clinical condition of the patient permitted (2-5 days postburn).


OutcomesBurn wound infection (defined as > 105 organisms/g of tissue in both the nonadherent graft and recipient site).

Hospital stay (days).

Antibiotic-resistant organisms.


NotesQuote: "The study was originally designed to include 90 patients; however, intermittent analysis showed that poor results occurred in two of the three groups (NB and RL), and therefore, data were evaluated after 45 patients had completed the study" (Page 1060 trial report).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskCards shuffled at assignment. Quote: "Patients were selected at random to receive one of the three treatments . . . Randomization was achieved by labelling 10 cards for each topical agent in each of three percentage total body surface area (TBSA) burn categories, specifically, less than 20 percent, 20 to 40 percent, and more than 40 percent" (Page 1060 trial report).

Allocation concealment (selection bias)Unclear riskQuote: "The cards were shuffled and drawn in blinded fashion when the patient was entered into the study" (Page 1060 trial report).

Comment: did not provide sufficient information to permit a judgement to be made.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo information provided.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information provided.

Incomplete outcome data (attrition bias)
All outcomes
High riskOnly 52/90 randomised patients included in the analysis.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasHigh riskQuote: "The study was originally designed to include 90 patients; however, intermittent analysis showed that poor results occurred in two of the three groups (NB and RL), and therefore, data were evaluated after 45 patients had completed the study" (Page 1060 trial report).

Maya 1986

MethodsStudy design: randomised controlled trial.

Setting/location: hospital (Hospital Infantil de Tacubaya de los Servicios Médicos del D.D.F.). Country: Mexico.

Period of study: not stated (published in 1986).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: yes.


ParticipantsInclusion criteria:

1. Paediatric patients.

2. 2nd-degree burns.

3. Patients admitted to the hospital.

Exclusion criteria: not described.

Randomised: 40 patients (Intervention group: n = 20, Control group: n = 20).

Patients assessed: 40 patients (100%).

Age (months): (mean, SD): Intervention group: 45.65 (26.87), Control group: 35.45 (26.44).

Gender (male: female): Intervention group: 12 (60%): 8 (40%), Control group: 11 (55%): 9 (45%).

Burned surface (% TBSA): (mean, SD): Intervention group: 12.25% (7.8), Control group: 12.65% (8).

TBSA full thickness burns: Intervention group: 3 (15%), Control group: 2 (10%).

Inhalation injury: not stated.

Time post-burn (h): (mean): Intervention group: 11.75 h, Control group: 14.87 h.

Burn type: Intervention group: scald (hot liquid or steam) 17 (85%), fire (flame) 3 (15%); Control group: scald 16 (80%), fire 2 (10%), chemical 2 (10%).

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: rifamycin and amniotic membranes vs amniotic membranes.

Intervention group: amniotic membranes and rifamycin.

Rifamycin was sprayed over the amniotic membranes. Membranes were kept dry, and sprayed again with rifamycin in case of apparent discharge.
Control group: amniotic membranes.

Amniotic membranes were separated from the chorion. Then they were washed in 250 ml 0.9% saline solution plus 1 g of neomycin. Membranes were stored at 4ºC for 14 days. Cultures of control were conducted every five days to verify the absence of bacterial contamination. Afterwards, they were used for treatment. In both groups, once the membranes had been placed, they were stretched over the burn area and dried with a hair dryer. In case of slippage or infection, the amniotic membranes were changed.

Duration of intervention: until wound healing (16 days).

Co-interventions: mechanical wash with Isodine and debridement of necrotic tissue, including blisters. Fluid replacement.


OutcomesLOS (days)

Wound infection

Time to re-epithelialization (days)


NotesWe tried to contact authors to obtain data on time to re-epithelialization, given that the study did not provide enough information on this matter, but It was not possible to obtain data that could be used for our review.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Forty patients with second-degree burns were treated with amniotic membranes and rifamycin. They were randomly assigned to two treatment groups " (Page 73 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo blinding described (therefore, probably open).

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information provided.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDid not report number of withdrawals.

Comment: denominator values suggested complete follow- up.

Selective reporting (reporting bias)High riskNo protocol provided, and none of the outcomes reported were nominated in the methods section of this paper.

Other biasUnclear riskInsufficient information to assess whether an important risk of bias existed.

Miller 1987

MethodsStudy design: randomised clinical trial.

Setting/location: hospital (Regional Burn Center, San Diego, California). Country: USA.

Period of study: not stated (published in 1987).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: no.


ParticipantsInclusion criteria:

1. Age: 18-67 years.

2. Gender: men and women.

3. Full-tickness burn injury.

4. Admitted within 72 h of burn injury.

5. Requirement for surgical excision and autografting.

Exclusion criteria:

1. Pregnant or breastfeeding women.

2. Impaired renal function (serum creatinine ≥ 1.5 mg%).

3. History of hypersensitivity to penicillin and cephalosporin.

4. Those who received antimicrobial drug therapy within 72 h preceding administration of preoperative study drug, or who were likely to receive concomitant antibiotics.

Randomised: 48 patients (Group 1: n = 24, Group 2: n = 24).

Excluded (post-randomisation): 7 (14.5%) (Group 1: 2 (8.3%), Group 2: 5 (20.8%)).

Reason for exclusion:

Did not receive ceforanide: 1 (Group 1).

Received additional antibiotic therapy after surgery: 1 (Group 1), topical antimicrobial: 1 (Group 2).

Premature hospital discharge: 1 (Group 2).

Late administration of the first dose of study drug: 1 (Group 2).

Concurrent administration of other antibiotics during the study period: 1 (Group 2).

Graft loss, due to inadequate operative debridement: 1 (Group 2).

Patients assessed: 47 patients (97.9%) (Group 1: 23, Group 2: 24).

Number evaluable: 41 patients (87.2%), Group 1: 22 (95.6%), Group 2: 19 (79.1%).

Age (years): (mean, range): Group 1: 34 (18-67), Group 2: 35 (20-65).

Burned surface (% TBSA): (mean, range): Group 1: 7.9% (2-22%), Group 2: 6% (2-15%).

Inhalation injury: not stated.

Time post-burn (h): ≤ 72 h (in both groups).

Burn type: not stated.

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: systemic antibiotic prophylaxis (perioperative).

Type of interventions: ceforanide vs cefazolin.

Group 1: ceforanide (1 g iv within 1 h prior to surgery).
Group 2: cefazolin (3 x 1 g iv doses, 1st within 1 hour of surgery, then doses at 6 h and 12 h after 1st dose)

Duration of intervention: during perioperative period (1 day).

Co-interventions: not described.


OutcomesInfection.

Burn wound infection (bacterial culture).

Cultures and sensitivities.

Overall prophylactic response (freedom of infection and successful graft take).

Side effects.


NotesSources of support: quote: "This study was supported in part by an educational graft from Bristol Myers, lnc." (Page 951 trial report).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "After randomisation, patients received either ceforanide 1 gm intravenously within one hour prior to surgery or three 1 gm doses of cefazolin, given intravenously within one hour of surgery . . . " (Page 948 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
High riskQuote: "An open-labelled, randomised, single-centre study" (Page 946).

Blinding of outcome assessment (detection bias)
All outcomes
High riskQuote: "An open-labelled, randomised, single-centre study" (Page 946 trial report).

Incomplete outcome data (attrition bias)
All outcomes
Low risk22/24 (92 %) and 19/24 patients (79%) in the ceforanide and in the cefazolin groups, respectively, were included in the final analysis.

Comment: not all randomised patients were included in the final analysis.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasLow riskThe study appeared to be free of other sources of bias.

Mohammadi 2009

MethodsStudy design: randomised clinical trial.

Setting/location: hospital (Ghotbeddin Burn Hospital, Shiraz). Country: Iran.

Period of study: October 2005-February 2007 (16 months).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: unclear.


ParticipantsInclusion criteria:

1. Patients with deep burns (2nd- and 3rd-degree).

2. Burns over 20-50% TBSA.

3. Patients admitted to burn centre.

Exclusion criteria:

1. Age: > 60 years.

2. History of cardiac disease, renal failure, diabetes mellitus or any other severe metabolic disorder.

Randomised: 124 patients (Group 1: n = 63, Group 2: n = 61).

Excluded (post-randomisation): Group 1 (control group): 1 (1.6%). Reasons for exclusion: Quote: "... an 18-year-old female, a case of suicide with 40% burn, who underwent amniotic membrane dressing. On the 5th day, the patient had high grade fever due to which her dressing was changed to regular antibiotic and gauze dressing. She was expired on the 14th day of hospitalization. This was the only case whose treatment policy was changed during hospitalization and so she was excluded from the survey".

Withdrawals: Group 2: 5 (8.6%) (2 males and 3 females). Reasons: died during the study.

Age (years): (mean): Group 1: 23.31 ± 14.53, Group 2: 25.3 ± 11.81.

Gender (male: female): Group 1: 35 (55.5%): 28 (44.4%), Group 2: 35 (57.3%): 26 (42.6%).

Burned surface (% TBSA): (mean): Group 1: 32.4% ± 8.9%, Group 2: 31.2% ± 8.3%.

TBSA full thickness burns: Group 1: 63 (100%), Group 2: 61 (100%).

Inhalation injury: not stated.

Time post-burn (h): not stated.

Burn type: in both groups most common mechanism was flame followed by flash.

Wounds infected at baseline?: no.

Co-morbidity: no comorbidity.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: amniotic membrane vs SSD.

Group 1: amniotic membrane.

Wounds were washed with normal saline and diluted Betadine and then covered with a layer of amniotic membrane, then a layer of Vaseline gauze, and a dressing with gauze and band.

Placentas were acquired from elective caesarean sections. The amniotic membrane was separated from chorion and placenta and washed thoroughly with normal saline, kept in a sterile pot of normal saline plus 80 mg gentamycin, and stored in refrigerator at 4°C. A blood sample drawn from the umbilical cord was checked for syphilis (VDRL test), HIV, HCV, and HBS, and, only if all these tests were negative, was the amniotic membrane used.

Dressings were changed every 3-4 days.

Group 2: SSD or mafenide acetate.

Wounds were irrigated twice daily with normal saline and diluted Betadine and then covered with SSD, or in some cases mafenide acetate dressing.

Duration of intervention: before skin graft (26 days).

Co-interventions: not described.


OutcomesWound infection.

Sepsis (suspected as present with the following symptoms: signs of hypothermia, hypotension, abrupt hyperglycaemia, decreased urine output, thrombocytopenia and diet intolerance, including blood culture and urine culture).

LOS (days).

Mortality.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: " . . . were admitted in our center were randomly divided into two groups, using random allocation (regardless of the depth of the burn)" (Page 67 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskQuote: "In this double-blinded randomised clinical trial".

Comment: it is not clear who was blinded.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskQuote: "In this double-blinded randomised clinical trial"

Comment: it is not clear who was blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: it is not clear how the authors considered the post randomisation exclusions and withdrawals in the analysis, however, due to their low number (6/124, i.e. 5%) they may have not distorted the study results.

Selective reporting (reporting bias)High riskNo protocol provided, and some of the outcomes reported were listed in the methods section of the trial report.

Other biasUnclear riskInsufficient information to assess whether an important risk of bias existed.

Moharamzad 2010

MethodsStudy design: double-blinded, randomised clinical trial.

Setting/location: hospital. Country: Iran.

Period of study: not stated (published in 2010).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: unclear.


ParticipantsInclusion criteria:

1. Burn patients.

2. Admitted to hospital < 24 h after burn injury.

3. 2nd-degree burns (partial-thickness burns).

4. Burns over ≤ 5% TBSA.

Exclusion criteria: not stated.

Randomised: 111 patients (Group 1: n = 55, Group 2: n = 56).

Withdrawals: not stated.

Burned surface (% TBSA): ≤ 5%.

Inhalation injury: not stated.

Time post-burn (h): ≤ 24 h.

Burn type: not stated.

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: SSD vs herbal cream.

Group 1: SSD topically once daily.
Group 2: herbal cream (Aloe vera, Geranium robertianum, and Lavandula stoechas) topically once daily.

Duration of intervention: 14 days.

Co-interventions: debridement and cleaning the wound.


OutcomesDuration of wound healing.
Wound infection.


NotesWe only had data published in an abstract.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Patients: In this double-blinded randomised clinical trial".
Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "In this double-blinded randomised clinical trial"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "In this double-blinded randomised clinical trial"

Comment: probably done.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information to permit judgement of ‘low risk’ or ‘high risk’.

Selective reporting (reporting bias)Unclear riskInsufficient information in poster report.

Other biasUnclear riskInsufficient information to assess whether an important risk of bias existed.

Muangman 2006

MethodsStudy design: randomised controlled trial.

Setting/location: hospital (Burn Unit, Siriraj Hospital). Country: Thailand.

Period of study: May 2002-September 2005 (3.4 years).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: yes.


ParticipantsInclusion criteria:

1. Partial-thickness burn wounds.

2. Burns < 25% TBSA.

3. Patients admitted to Burn Unit.

Exclusion criteria: not described.

Randomised: 50 patients (Group 1: n = 25, Group 2: n = 25).

Patients assessed: 50 (100%).

Age (years): (mean, SD): Group 1: 38 ± 25, Group 2: 26 ± 27.

Burned surface (% TBSA): (mean, SD): Group 1: 15 ± 7, Group 2: 15 ± 5.

Inhalation injury: not stated.

Time post-burn (h): not stated.

Burn type: Group 1: fire (flame) 14 (56%), scald (hot liquid or steam) 9 (36%), electrical 1 (4%), chemical 1 (4%); Group 2: fire 12 (48%), scald 12 (48%), chemical 2 (10%), electrical 1 (4%).

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: silver-coated dressing vs SSD.

Group 1: Acticoat (Smith & Nephew USA, Largo, FL), a non-adherent nanocrystalline silver-coated dressing material.

Acticoat, moistened in sterile water, was applied, then a dry dressing. The inner gauze was moistened twice a day with sterile water and the Acticoat was changed every 3 days.

Group 2: SSD 1% and dry gauze dressings twice daily.

Duration of intervention: until burn wound closure.

Co-interventions: all patients were routinely given 2 x 500 mg tablets of acetaminophen (paracetamol) before dressing changes.


OutcomesLOS (days).

Days until burn wound closure.

Type of cultured organisms.

Wound colonization (bacterial culture and signs of infection such as erythema, induration, purulent discharge and malodour).

Infection.

Mortality.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Fifty patients were identified and randomised into 2 groups and given burn wound treatment . . . " (Page 954 trial report).

No significant differences in age, TBSA (%), type of burn, length of hospital stay, between the two groups.

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo information provided.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information provided.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDid not report number of withdrawals.

Comment: denominator values suggested complete follow-up.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasLow riskThe study appeared to be free of other sources of bias.

Munster 1986

MethodsStudy design: randomised, prospective study.

Setting/location: hospital (Baltimore Regional Burn Center, Maryland). Country: USA.

Period of study: not stated (published in 1986).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: yes.


ParticipantsInclusion criteria:

1. Age: 18-50 years.

2. Burns 20%-70% TBSA.

3. Patients admitted to Burn Center.

Exclusion criteria:

1. Tests of hepatic and renal function with abnormal values (post-randomisation).

Participants: 28 patients (Intervention group: n = 15, Control group: n = 13).

Withdrawals: no patient had to be discontinued from the study because of adverse side effects, or adverse effects on renal or hepatic function.

Age (years): (mean, SD): Intervention group: 36.9 ± 12, Control group: 40 ± 15.9.

Burned surface (% TBSA): (mean, SD): Intervention group: 30.8 ± 8.5, Control group: 38.4 ± 17.3.

Inhalation injury: not stated.

Time post-burn (h): not stated.

Burn type: Intervention group: thermal (100%), Control group: thermal (100%).

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: systemic antibiotic prophylaxis (general).

Type of interventions: polymixin B vs control.

Intervention group: polymixin B 5000 units/kg iv on 1st day of study, reducing by increments of 500 units/kg/day to 1500 units on last day.
Control group: untreated patients.

Duration of intervention: 7 days.

Duration of follow-up: 2 weeks.

Co-interventions: not described.


OutcomesBurn wound sepsis (determined by presence of ≥ 105 organisms/g tissue).

Sepsis (determined by either: (1) presence of a positive blood culture; or, (2) presence of a quantitative biopsy on one or more occasion of ≥ 105 organisms/g tissue, coupled with any one of the following clinical parameters: hypothermia, disorientation and paralytic ileus).

Mortality.


NotesSources of support: quote: "Supported in part by NIH Grant GM 26235 and by the Baltimore Metropolitan Firefighters Unions" (Page 995 trial report).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "All patients were admitted . . . following which they were randomised to polymyxin or control group" (Page 995 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants and study personnel not reported, but probably not done due to the different nature of the interventions (polymixin iv vs no treatment).

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskBlinding of outcome assessors not reported.

Incomplete outcome data (attrition bias)
All outcomes
Low riskThe authors stated that, "A total of 28 patients completed the study, 15 in the polymixin and 13 in the control group".

Quote: "No patient had to be discontinued from the study because of adverse side effects or adverse effects on renal or hepatic function" (Page 996 trial report).

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes nominated in the methods section, all pre-specified outcomes were reported.

Other biasUnclear riskInsufficient information provided to enable an assessment of whether an important risk of bias existed.

Noordenbos 1999

MethodsStudy design: prospective, randomised, paired-site study.

Setting/location: hospital (San Diego Medical Center, California). Country: USA.

Period of study: 1 year.

Unit of randomisation: wound site.

Unit of analysis: wound site.

Sample size calculation: no.

Use of ITT analysis?: no.


ParticipantsInclusion criteria:

1. Age: 1-70 years.

2. Partial-thickness burns (moderate to deep partial-thickness in depth, i.e. wounds that it was estimated would require 7-21 days to heal).

3. Burns 2%-30% TBSA.

Exclusion criteria:

1. Wounds of the hands, face, buttocks, feet, and genitalia.

Randomised: 14 patients, 28 wound sites: Group 1: n = 14, Group 2: n = 14.

Patients assessed: 11 patients (78.6%).

Age (years): (mean, range): 23.4 (1.1-52), SD: 19.4.

Burned surface (% TBSA): (mean, range): 13.3% (4-30), SD: 7.2.

Inhalation injury: not stated.

Time post-burn (h): unclear, quote: "Attempts were made to enrol patients into the study as soon as possible after injury" (Page 276).

Burn type: not stated.

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: biosynthetic dressing (TransCyte) vs SSD.

Group 1: biosynthetic dressing (TransCyte (Advanced Tissue Sciences, La Jolla, California, USA), twice-daily. TransCyte was never applied more than 24 h postburn.

Group 2: SSD (BASF Inc, Mt Olive, New Jersey, USA) applied topically twice daily.

Duration of intervention: until wound was clean of necrotic tissue and debris.

Co-interventions: wound debridement according to standard protocol of the burn centre. All cases of cellulitis were solved with short cycles of intravenous antibiotics.


OutcomesTime until 90% healing (number of days until epithelial closure of at least 90% of the study site wound).

Burn wound infection.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "After patients were enrolled into the study, the 2 wound sites were chosen randomly to received either topical therapy with SSD (BASF Inc, Mt Olive, NJ) and twice-daily dressing changes or TransCyte" (Page 276 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskBlinding of participants and study personnel not reported.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskBlinding of outcome assessors not reported.

Incomplete outcome data (attrition bias)
All outcomes
High riskNot all patients who were randomised were included in the final analysis, and this may cause attrition bias.

Comment: the magnitude of losses during the study was > 20%.

Selective reporting (reporting bias)High riskNo protocol provided, and some of the outcomes reported were listed in the methods section of the trial report.

Other biasUnclear riskInsufficient information to assess whether an important risk of bias existed.

Rodgers 1997

MethodsStudy design: randomised, prospective, partially-blinded study.

Setting/location: hospital (St Christopher's Hospital for Children, Pennsylvania). Country: USA.

Period of study: October 1993-September 1994 (11 months).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: no.


ParticipantsInclusion criteria:

1. Patients admitted for care of burns.

2. Burns < 35% TBSA.

3. Requirement for surgical debridement and grafting.

Exclusion criteria:

1. Clinical evidence of infection at the time of debridement.

2. Received antibiotic therapy before debridement.

3. History of allergy to penicillin or cephalosporins.

Randomised: 48 patients (42 patients < 35% TBSA; 6 patients > 35% TBSA).

One patient with ≥ 35% TBSA burns was re-entered into the randomisation for a 2nd debridement procedure.

Excluded (before randomisation): < 35% TBSA burned: 21 patients (50%); > 35% TBSA burned: 3 patients (50%).

Reason for exclusion:

Failure to consent: 10 patients < 35% TBSA burned.

Receipt of antibiotics before surgical debridement: < 35% TBSA burned: 10 patients, > 35% TBSA burned: 3 patients.

Allergy to penicillin: < 35% TBSA burned: 1 patient.

Withdrawals: < 35% TBSA burned: Intervention group: 1 (2%). Reasons: became hypotensive and hypothermic during surgery and was not responsive to volume resuscitation.

Patients assessed: 24 patients (50%).

< 35% TBSA burned: 20 patients (Intervention group: n = 10, Control group: n = 10).

> 35% TBSA burned: 4 patients (Intervention group: n = 3, Control group: n = 1).

Age (years): (mean):

< 35% TBSA: Intervention group: 1.5, Control group: 1.9.

> 35% TBSA: Intervention group: 5.4, Control group: 8.

Gender (male: female):

<35% TBSA: Intervention group: 6 (60%): 4 (40%), Control group: 4 (40%): 6 (60%).

>35% TBSA: Intervention group: 3 (100%): 0, Control group: 1 (100%): 0.

Burned surface (% TBSA): (mean):

<35% TBSA: Intervention group: 10%, Control group: 11%.

>35% TBSA: Intervention group: 45%, Control group: 55%.

TBSA full thickness burns: > 35% TBSA: Intervention group: 3 (100%), Control group: 1 (100%).

Inhalation injury: not stated.

Time post-burn (h): not stated.

Burn type:

< 35% TBSA: Intervention group: scald (hot liquid or steam) 9 (90%), fire (flame) 1 (10%); Control group: scald 6 (60%), fire 2 (20%), electrical 1 (10%), contact (hot solids) 1 (10%)

> 35% TBSA: Intervention group: fire 3 (100%), Control group: fire 1 (100%)

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: systemic antibiotic prophylaxis (perioperative).

Type of interventions: cefazolin vs placebo, cefazolin vs targeted antibiotics.

< 35% TBSA

Intervention group: iv cefazolin 25 mg/kg 6-hourly for 24 h. Administered in the operating room after a blood culture.

Control group: placebo (normal saline in the volume corresponding to the cefazolin dose).

> 35% TBSA

Intervention group: iv cefazolin 25 mg/kg 6-hourly for 24 h.

Control group: targeted antibiotics in the volume corresponding to the cefazolin dose (selected by the infectious diseases consultant based on the results of the latest surveillance cultures).

Duration of intervention: perioperative (1 day).

Co-interventions: surgical debridement of the burn wound .


OutcomesInfection (bacteraemia).

Organisms isolated.

Burn wound infection (quantitative tissue biopsy cultures).


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "After categorization of TBSA burn, patients were randomised to treatment groups with use of a standard random number table" (Page 343 trial report).

Allocation concealment (selection bias)Unclear riskComment: no information provided

Blinding of participants and personnel (performance bias)
All outcomes
High riskQuote: "All antibiotics and placebo were prepared by the hospital pharmacy and administered by one unblinded investigator (GR)" (Page 343).

There was not enough information about blinding of participants, although it was reported that the professional who administered the intervention was not blinded.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "All grafts were inspected by one of two attending plastic surgeons (who were blinded to study treatment assignment) . . . " (Page 343 trial report).

Incomplete outcome data (attrition bias)
All outcomes
Low risk20/21 (95 %) and 4/4 (100%) in the < 35% TBSA group and in the ≥ 35% TBSA group, respectively, were included in the final analysis.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasLow riskThe study appeared to be free of other sources of bias.

Silver 2007

MethodsStudy design: open, prospective, single-centred, parallel group.

Setting/location: hospital (Loyola University Medical Center, Chicago). Country: USA.

Period of study: December 2003-January 2005 (1.1 years).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: yes.


ParticipantsInclusion criteria:

1. Age: ≥ 13 years.

2. Burn requiring grafting with meshed autografts.

3. Consent according to institutional research board guidelines.

Exclusion criteria:

1. Clinically significant history of major system disorder.

2. Active immunosuppressive therapy.

3. Pregnant or breastfeeding.

4. Chemotherapy or radiation therapy.

5. Immunocompromised state.

6. Sensitivity to silver or sulphonamide.

7. Clinical wound infection before enrolment.

Randomised: 20 patients (Group 1: n = 10, Group 2: n = 10).

Patients assessed: 20 patients (100%).

Withdrawals: not stated.

Age (years): (mean, range): Group 1: 41.4 ± 15.8, Group 2: 44.0 ± 17.9.

Gender (male: female): Group 1: 6 (60%): 4 (40%), Group 2: 8 (80%): 2 (20%).

Burned surface (% TBSA): (mean, SD): Group 1: 17 ± 9.9, Group 2: 18.7 ± 10.3.

Inhalation injury: not stated.

Time post-burn (days): not stated.

Burn type: not stated.

Wounds infected at baseline?: no

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: mafenide acetate vs silver dressing.

Group 1: mafenide acetate (Sulfamylon® 5% topical solution) applied through dressing (Exu-Dry, Smith & Nephew) soaked in the solution. Dressing was left on for 3 days, then changed every 3 days.

Group 2: silver dressing (Acticoat, Smith & Nephew Inc. Largo, Florida, USA).

The dressing stayed intact for 2 days, and was then changed daily.

Duration of intervention: until complete healing, or 2 weeks from initial assessment.

Co-interventions: not described.


OutcomesHealing time.

Infectious complications.

Adverse effects.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "All wounds were placed in 5% sulfamylon solution except test sites in the group of subjects randomised to Acticoat" (Page 716 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
High riskQuote: "The study was designed as an open, prospective, single center, parallel group, comparative evaluation . . ." (Page 716 trial report).

Blinding of outcome assessment (detection bias)
All outcomes
High riskQuote: "The study was designed as an open, prospective, single center, parallel group, comparative evaluation . . . " (Page 716 trial report).

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskAltough the authors stated that "there were no withdrawals from the study" (Page 718), there was insufficient information to permit judgement of ‘low risk’ or 'high risk’ for incomplete outcome data, as the denominators of the comparisons for each outcome were not reported.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasUnclear riskInsufficient information to assess whether an important risk of bias existed.

Soroff 1994

MethodsStudy design: pilot study.

Setting/location: hospital (Hospital Institutional Review Board, Minnesota). Country: USA.

Period of study: not stated (published in 1994).

Unit of randomisation: burn wound.

Unit of analysis: burn wound.

Sample size calculation: no.

Use of ITT analysis?: no.


ParticipantsInclusion criteria:

1. Age: ≥ 18 years.

2. Partial-thickness burns (defined as partial destruction of the dermal layer with dead tissue adherent to underlying viable dermis).

3. Two wounds of similar size and severity (noncontiguous).

Exclusion criteria:

1. Chemical or electrical burns.

2. Burns ≥ 25% TBSA.

3. Known hypersensitivity to collagenase, silver sulfadiazine, polymyxin B sulfate, or bacitracin.

4. Pregnant or breastfeeding women.

Randomised: 15 patients (30 burn wounds).

Excluded (post-randomisation): 2 (13.3%).

Reason for exclusion: refused treatment (1); had an infection at an unrelated burn site (1).

Assessed: 13 patients (86.6%).

Age (years): not stated.

Gender (male: female): 14 (93.3%): 1 (6.6%).

Burned surface (% TBSA): (mean, SD): 11.7 ± 9.7 (range 2%-34%).

TBSA full thickness burns: > 25% TBSA: 1 (34%), 1 (30%).

Inhalation injury: not stated.

Time post-burn (h): not stated.

Burn type: scald (hot liquid or steam) 5 (33.3%), fire (flame) 5 (33.3%), other agents (hot ashes, flash, combined flame/flash) 5 (33.3%).

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: polymyxin B sulfate/bacitracin vs SSD.

Group 1 (1st burn site): polymyxin B sulfate/bacitracin spray, covered with collagenase ointment, topically administered twice daily.
Group 2 (2nd burn site): SSD cream, topically administered twice daily .

Before treatment wound cultures were taken, and burns cleansed with normal saline solution.

Duration of intervention: until wound bed was clean (disappearance of injured dermis).

Co-interventions: not described.


OutcomesTime to wound healing.

Adverse events.


NotesIn total, only 15 patients for both treatment groups were treated for different, non-contiguous wounds.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Two noncontiguous burns of similar size and severity were treated according to a randomisation schedule" (Page 13 trial report).

Comment: insufficient information provided to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNo information provided (probably an open trial due to the different natures of the interventions (spray + ointment versus cream).

Blinding of outcome assessment (detection bias)
All outcomes
High riskBlinding of outcome assessors not reported, and probably not done, because of the different natures of the interventions (spray + ointment versus cream).

Incomplete outcome data (attrition bias)
All outcomes
Low risk13/15 (87%) and 13/15 burn wounds (87%) in the collagenase and in the control groups, respectively, were included in the final analysis. Incomplete outcome data probably did not distort the study results.

Selective reporting (reporting bias)High riskNo protocol provided, and none of the outcomes reported were listed in the methods section of the trial report.

Other biasLow riskThe basal characteristics of participants did not present significant differences between comparison groups.

Subrahmanyam 1998

MethodsStudy design: prospective randomised trial.

Setting/location: hospital (Department of Surgery, Dr Vaishampayan Memorial Medical College, Maharashtra). Country: India.

Period of study: June 1995-December 1996 (18 months).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: yes.


ParticipantsInclusion criteria:

1. Superficial burns.

2. Burns ≥ 40% TBSA.

3. Treated within 6 h of burn injury.

Exclusion criteria: not stated.

Randomised: 50 patients (Group 1: n = 25, Group 2: n = 25).

Withdrawals: not stated.

Age (years): (mean, range): Group 1: 25.2 (3-58), Group 2: 26.4 (5-60).

Gender (male:female): Group 1: 14 (56%):11 (44%), Group 2: 13 (52%):12 (48%).

Burned surface (% TBSA): (mean, range): Group 1: 14.5% (10-38), Group 2: 15.6% (10.5-40).

Inhalation injury: not stated.

Time post-burn (h): ≤ 6 h.

Burn type: Group 1: fire (flame) 23 (92%), scald (hot liquid or steam) 2 (8%), Group 2: fire 22 (88%), scald 3 (12%).

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: honey vs SSD.

Group 1: honey (pure, unprocessed, undiluted, obtained from hives), applied topically daily and at the time of dressing.

Group 2: SSD applied topically daily.

Burns were washed with normal saline prior to the intervention.

Duration of intervention: until wounds healed.

Co-interventions: not described.


OutcomesRates of wound healing (assessed clinically and histologically on days 7 and 21).

Wound infection (bacterial cultures, biopsies and clinical assessment).

Proportion of participants with completely healed wounds.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "After the initial management, patients were allocated at random to two groups" (Page 157 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNo information provided (probably an open trial due to the different nature of the interventions (honey versus SSD). The antibiotic was applied topically, and was obviously different to the intervention administered in the control group, so we assumed that the participants, personnel and outcome assessors were not blinded.

Blinding of outcome assessment (detection bias)
All outcomes
High riskBlinding of outcome assessors not reported, but probably not done because of the different nature of the interventions (honey versus SSD).

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDid not report number of withdrawals

Comment: denominator values suggested complete follow- up.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasLow riskThe study appeared to be free of other sources of bias.

Tayade 2006

MethodsStudy design: prospective controlled trial.

Setting/location: hospital and outpatient (Department of Surgery, Grant Medical College and Sir J.J. Group of Hospitals, Mumbai). Country: India

Period of study: February 2002-August 2004 (2.6 years).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: yes.


ParticipantsInclusion criteria:

1. Age: patients of any age.

2. Partial-thickness burns.

3. Burns ≤ 15% TBSA.

4. Thermal burns or scalds.

5. Burns sustained up to 24 h prior to treatment.

6. Superficial burns not requiring any kind of graft.

Exclusion criteria: not described.

Randomised: 50 patients (Group 1: n = 25, Group 2: n = 25).

Patients assessed: 50 patients (100%).

Age (years): (range): 11-30.

Burned surface (% TBSA): < 10% (both groups).

Inhalation injury: not stated.

Time post-burn (h): < 24 h (both groups).

Burn type: Group 1: scald (hot liquid or steam) 9 (36%), fire (flame)16 (64%), Group 2: scald 10 (40%), fire 15 (60%).

Wounds infected at baseline?: no.

Co-morbidity: not described.


InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: SSD vs collagen sheet.

Group 1: SSD 1%.

Group 2: collagen sheet (Kollagen, enzymatically prepared from cattle skin), membrane was applied to the wound after thorough cleansing with chlorhexidine solution and thorough debridement of blisters.

Both treatments were topically administered daily.

Duration of intervention: until complete epithelization (mean:15.54 days).

Co-interventions: NSAIDs used as first line analgesics with intramuscular (im) pentazocine as second line.


OutcomesHealing time (days).

Burn wound infection (presence of pus and conversion to full-thickness wounds).

Adverse events (allergic or hypersensitivity reactions).


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Each patient was then randomly allocated to either of the groups with subsequent application of collagen sheet or silver sulphadiazine respectively", "Hence the two groups were compatible with each other in respect of age, sex ratio and type of burns ( Table 1)" (Page 2 trial report).

Comment: insufficient information to make a judgement.

Allocation concealment (selection bias)Unclear riskNo information provided.

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of participants and key study personnel not reported, but probably not done due to the different nature of the interventions (SSD vs collagen sheet).

Blinding of outcome assessment (detection bias)
All outcomes
High riskBlinding of outcome assessors not reported, but probably not done due to the different nature of the interventions (SSD vs collagen sheet).

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDid not report number of withdrawals.

Comment: denominator values suggested complete follow-up.

Selective reporting (reporting bias)Low riskNo protocol provided, but given the outcomes listed in the methods section, all pre-specified outcomes were reported.

Other biasLow riskThe study appeared to be free of other sources of bias.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Abdel-Razek 2000Inappropriate comparison. All patients received the same antibiotic (used the same treatment with selective gastrointestinal decontamination in two arms).

Afilalo 1992Relevant data were not reported or available from the authors.

Ahuja 2009None of the review outcomes was assessed.

Baghel 2009Wounds were already infected before treatment. The study reported data on patients with positive cultures in the wound at the beginning of the study.

Branski 2008Inappropriate comparison (used the same antibiotic in both arms).

Carneiro 2002Wounds were already infected before treatment. The study reported data on patients with positive cultures in the wound at the beginning of the study.  

Cason 1966Quasi-randomised.

De Gracia 2001Inappropriate comparison (used the same antibiotic in both arms).

Deutsch 1990Quasi-randomised.

Donati 1994Inappropriate intervention. All patients received the same antibiotic. An immunological treatment was the only one randomised.

Fang 1987Inappropriate comparison (used the same antibiotic in both arms).

Grippaudo 2010Even though the authors had mentioned in the abstract that the outcome of burn wound infection had been assessed, the study report did not include the data. We tried to contact the authors, but it was not possible to obtain data that could be used in our review

Huang 2006Preliminary report of Huang 2007 (see below).

Huang 2007Study assessed management of residual wounds postburn - wounds were infected before treatment.

Hunter 1976Quasi-randomised.

Inman 1984Inappropriate comparison (used the same antibiotic in both arms).

Li XL 2006Study assessed management of residual burn wounds.

Lowbury 1968Quasi-randomised.

Malik 2010Quasi-randomised.

Manuskiatti 1999Quasi-randomised.

Mashhood 2006None of the review outcomes was assessed.

Miller 1990Inadequate comparison (used the same antibiotic in both arms).

Munster 1989Quasi-randomised.

Oen 2012Inappropriate comparison (used the same antibiotic in both arms).

Ostlie 2012Inappropriate intervention. All patients received the same antibiotic (SSD) at the beginning of the study. Quote: "After the initial debridement on admission, all patients were dressed with SSD, which was used for the first 2 days of daily debridement. After 2 days, patients were then randomized to continue daily debridement with either SSD or CO for up to10 days" (Page 1205).

Piel 1985Even though the authors mentioned in the abstract that the outcome of burn wound infection had been assessed, the study report did not include the data. We tried to contact the authors, but it was not possible to obtain data that could be used in our review

Proctor 1971Quasi-randomised.

Ramos 2008Wounds were already infected before treatment. The study reported data on patients with positive cultures in the wound at the beginning of the study.  Quote: "The antibiotic regimen was chosen in accordance with the antibiogram of the bacteria isolated from the surveillance wound cultures done once a week. The group of patients with less than 4 days of hospital admission did not have surveillance wound cultures and Cephalothin iv was prescribed" (Page 918).

Steer 1997The analysis and reported data were not clear; authors reported 134 patients were randomised, but 86 patients who had been re-intervened or who had undergone change of dressing were included in several analyses. The trial was excluded because of lack of independent information for those patients receiving antibiotic prophylaxis as the first intention treatment. We tried unsuccessfully to contact the study authors to obtain data on these results.

Subrahmanyam 1991The wounds were already infected before treatment.

Ugburo 2004The study did not provide information that could be used for our review.

Varas 2005None of the review outcomes was assessed.

Waffle 1988Quasi-randomised.

 
Characteristics of studies awaiting assessment [ordered by study ID]
Maghsoudi 2011

MethodsStudy design: prospective randomised trial.

Setting/location: hospital (Sina Hospital, University of Medical Sciences of Tabriz). Country: Iran.

Period of study: 20 March 2010-20 March 2011 (1 year).

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: yes.

ParticipantsInclusion criteria:

1. Patients admitted to the hospital.

2. Superficial thermal burns.

3. Burns ≤ 40% TBSA.

Exclusion criteria: not stated.

Randomised: 100 patients (Group 1: n = 50, Group 2: n = 50).

Patients assessed: 100 (100%).

Withdrawals: not stated.

Age (years): (mean, range): Group 1: 26.4 (5-70), Group 2: 25.2 (3-68).

Gender (male: female): Group 1: 25 (50%): 25 (50%), Group 2: 23 (46%): 27 (54%).

Burned surface (% TBSA): (mean, range): Group 1: 15.6% (10.5-40), Group 2: 14.5% (10-40).

Inhalation injury: not stated.

Time post-burn (h): not stated.

Burn type: Group 1: fire (flame) 39 (78%), scald (hot liquid or steam) 11 (22%), Group 2: fire 43 (86%), scald 7 (14%).

Wounds infected at baseline?: no.

Co-morbidity: not described.

InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: mafenide acetate dressing vs honey dressing.

Group 1: after being washed with normal saline, wounds were covered with gauze impregnated with mafenide acetate. These dressings were replaced daily.
Group 2: honey was applied on alternate days and at the time of dressing. After spreading the honey, the wound was covered with dry, sterile gauze, and bandaged.

Duration of intervention: until healing.

Co-interventions: not stated.

OutcomesWound infection (the definitive diagnosis of burn wound infection was made with biopsy of > 105 organisms/g of tissue).

Time required for healing (days).
Clinical evidence of wound healing.

The organisms isolated in positive swab cultures.

Side effects.

LOS.

NotesAwaiting classification while authors of the trial report respond to a request for further information from the review authors.

Panahi 2012

MethodsStudy design: randomized and double-blinded clinical trial.

Setting/location: hospital (Baqiyatallah University of Medical Sciences of Tehran). Country: Iran.

Period of study: not stated.

Unit of randomisation: patient.

Unit of analysis: patient.

Sample size calculation: no.

Use of ITT analysis?: yes.

ParticipantsInclusion criteria:

1. Second-degree burns.

2. Burn type: thermal

3. Burns ≤ 5% TBSA.

4. Occurrence of burn in the preceding 48 hours.

5. Without presence of other injuries.

6. Good general physical and mental health.

Exclusion criteria:

1. Presence of any renal, hepatic, endocrine, cardiovascular or cerebrovascular disease.

2. Pregnancy.

3. History of drug or alcohol abuse.

4. Use (oral or topical) of antibiotics, steroids or immunosuppressive drugs.

Randomised: 120 patients (Group 1: n = 60, Group 2: n = 60).

Excluded (post-randomisation): Group 1: 5 (8.3%), Group 2: 4 (6.6%). Reason for exclusion: Quote: "From the initial 120 patients with superficial second-degree burn that were recruited into the study, nine were excluded due to study protocol violation." (Page 274).

Patients assessed: 111 (92.5%).

Withdrawals: not stated.

Age (years): (mean, range): Group 1: 37.4 (±12.7), Group 2: 33.6 (±13.4).

Gender (male: female): Group 1: 30 (54.5%): 25 (45.5%), Group 2: 35 (62.5%): 21 (37.5%).

Burned surface (% TBSA): (mean, range): Group 1: 2.38% (±1.42), Group 2: 2.48% (±1.45).

Inhalation injury: not stated.

Time post-burn (h): < 48 h after injury (both groups).

Burn agent: Group 1: fire (flame) 18 (32.7%), scald (hot liquid or steam) 33 (60%), contact (hot solids) 3 (5.5%), other (chemical substance) 3 (5.4%); Group 2: fire 22 (39.3%), scald (hot liquid or steam) 29 (51.8%), contact (hot solids) 2 (3.6%), other (chemical substance) 3 (5.4%).

Wounds infected at baseline?: no.

Co-morbidity: no chemical substance.

InterventionsType of antibiotic prophylaxis: topical antibiotic prophylaxis.

Type of interventions: SSD vs herbal cream.

Group 1: topical SSD 1% cream once a day.
Group 2: herbal cream once a day. The constituents of herbal cream were Aloe vera gel and essential oils from Lavandula stoechas and Pelargonium roseum.

In both groups, following cleansing and debridement of burn wounds with antimicrobial solution, cream (5 g for each 10 cm2 of burn area) was applied on wounds using a sterile spatula. After application of the creams, sterile gauze was applied and wounds bandaged.

Duration of intervention: until recovery.

Co-interventions:

not stated.

OutcomesSeverity of pain.

Frequency of skin dryness.

Infection.

NotesAwaiting classification while authors of the trial report respond to a request for further information from the review authors.

 
Comparison 1. Topical antibiotic prophylaxis

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Burn wound infection25Odds Ratio (Random, 95% CI)1.37 [1.02, 1.82]

    1.1 Neomycin, bacitracin and polymyxin B vs control/placebo
2Odds Ratio (Random, 95% CI)0.75 [0.32, 1.73]

    1.2 Silver sulfadiazine vs dressings or skin substitute
11Odds Ratio (Random, 95% CI)1.87 [1.09, 3.19]

    1.3 Silver sulfadiazine vs traditional medicine
4Odds Ratio (Random, 95% CI)1.05 [0.54, 2.06]

    1.4 Other topical antibiotics vs dressings or skin substitute
3Odds Ratio (Random, 95% CI)1.03 [0.19, 5.48]

    1.5 Antibiotic prophylaxis vs other treatments
7Odds Ratio (Random, 95% CI)1.51 [0.94, 2.42]

 2 Infections in the burned people (sepsis)3Risk Ratio (M-H, Random, 95% CI)Subtotals only

    2.1 Neomycin, bacitracin and polymyxin B vs control/placebo
299Risk Ratio (M-H, Random, 95% CI)7.58 [0.44, 130.38]

    2.2 Antibiotic prophylaxis vs other treatments
3227Risk Ratio (M-H, Random, 95% CI)4.31 [1.61, 11.49]

 3 Infections in burned people (bacteraemia)3Risk Ratio (M-H, Random, 95% CI)Totals not selected

    3.1 Neomycin, bacitracin and polymyxin B vs control/placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

    3.2 Silver sulfadiazine vs dressings or skin substitute
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

    3.3 Silver sulfadiazine vs traditional medicine
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

    3.4 Antibiotic prophylaxis vs other treatments
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 4 Infections in burned people (pneumonia)2Risk Ratio (M-H, Random, 95% CI)Totals not selected

    4.1 Neomycin, bacitracin and polymyxin B vs control/placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

    4.2 Silver sulfadiazine vs traditional medicine
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

    4.3 Antibiotic prophylaxis vs other treatments
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 5 Infections in burned people (urinary tract infection)1Risk Ratio (M-H, Random, 95% CI)Totals not selected

    5.1 Silver sulfadiazine vs traditional medicine
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 6 Adverse events7Odds Ratio (Random, 95% CI)Subtotals only

    6.1 Silver sulfadiazine vs polymyxin B/bacitracin
1Odds Ratio (Random, 95% CI)0.20 [0.02, 2.16]

    6.2 Silver sulfadiazine vs dressings or skin substitute
4Odds Ratio (Random, 95% CI)1.00 [0.47, 2.14]

    6.3 Other topical antibiotics vs dressings or skin substitute
1Odds Ratio (Random, 95% CI)1.0 [0.05, 18.57]

    6.4 Antibiotic prophylaxis vs other treatments
1Odds Ratio (Random, 95% CI)1.0 [0.06, 18.08]

 7 Infection-related mortality2Risk Ratio (M-H, Random, 95% CI)Totals not selected

    7.1 Neomycin, bacitracin and polymyxin B vs control/placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

    7.2 Silver sulfadiazine vs traditional medicine
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

    7.3 Antibiotic prophylaxis vs other treatments
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 8 Antibiotic resistance (MRSA)3Risk Ratio (M-H, Random, 95% CI)Totals not selected

    8.1 Neomycin, bacitracin and polymyxin B vs control/placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

    8.2 Silver sulfadiazine vs dressings or skin substitute
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

    8.3 Silver sulfadiazine vs traditional medicine
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

    8.4 Antibiotic prophylaxis vs other treatments
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 9 All-cause mortality5Risk Ratio (M-H, Random, 95% CI)Subtotals only

    9.1 Silver sulfadiazine vs dressings or skin substitute
2132Risk Ratio (M-H, Random, 95% CI)0.35 [0.01, 8.34]

    9.2 Silver sulfadiazine vs traditional medicine
1112Risk Ratio (M-H, Random, 95% CI)1.86 [0.17, 19.95]

    9.3 Antibiotic prophylaxis vs other treatments
2161Risk Ratio (M-H, Random, 95% CI)5.95 [1.10, 32.33]

 10 Length of hospital stay (LOS)8Mean Difference (IV, Fixed, 95% CI)Subtotals only

    10.1 Neomycin, bacitracin and polymyxin B vs control/placebo
133Mean Difference (IV, Fixed, 95% CI)-3.67 [-9.46, 2.12]

    10.2 Silver sulfadiazine vs dressings or skin substitute
4196Mean Difference (IV, Fixed, 95% CI)2.11 [1.93, 2.28]

    10.3 Antibiotic prophylaxis vs other treatments
4216Mean Difference (IV, Fixed, 95% CI)3.26 [1.45, 5.07]

 
Comparison 2. Systemic antibiotic prophylaxis (general)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Burn wound infection2Risk Ratio (M-H, Random, 95% CI)Subtotals only

    1.1 Antibiotic prophylaxis vs control/placebo
279Risk Ratio (M-H, Random, 95% CI)0.64 [0.07, 6.09]

 2 Infections in burned people (sepsis)2Risk Ratio (M-H, Random, 95% CI)Subtotals only

    2.1 Antibiotic prophylaxis vs control/placebo
279Risk Ratio (M-H, Random, 95% CI)0.43 [0.12, 1.61]

 3 Infections in burned people (bacteraemia)1Risk Ratio (M-H, Random, 95% CI)Totals not selected

    3.1 Antibiotic prophylaxis vs control/placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 4 Infections in burned people (pneumonia)1Risk Ratio (M-H, Random, 95% CI)Totals not selected

    4.1 Antibiotic prophylaxis vs control/placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 5 Infections in burned people (urinary tract infection)1Risk Ratio (M-H, Random, 95% CI)Totals not selected

    5.1 Antibiotic prophylaxis vs control/placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 6 Infection-related mortality2Risk Ratio (M-H, Random, 95% CI)Subtotals only

    6.1 Antibiotic prophylaxis vs control/placebo
279Risk Ratio (M-H, Random, 95% CI)0.27 [0.05, 1.58]

 7 Antibiotic resistance (MRSA)1Risk Ratio (M-H, Random, 95% CI)Totals not selected

    7.1 Antibiotic prophylaxis vs control/placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 8 All-cause mortality3Risk Ratio (M-H, Random, 95% CI)Subtotals only

    8.1 Antibiotic prophylaxis vs control/placebo
3119Risk Ratio (M-H, Random, 95% CI)0.41 [0.17, 1.02]

 9 Length of hospital stay (LOS)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    9.1 Antibiotic prophylaxis vs control/placebo
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 3. Systemic antibiotic prophylaxis (perioperative)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Burn wound infection3Risk Ratio (M-H, Random, 95% CI)Subtotals only

    1.1 Antibiotic prophylaxis vs control/placebo
2269Risk Ratio (M-H, Random, 95% CI)0.51 [0.03, 7.37]

    1.2 Cephazolin vs other antibiotic
251Risk Ratio (M-H, Random, 95% CI)0.99 [0.49, 2.01]

 2 Infections in burned people (bacteraemia)2Risk Ratio (M-H, Random, 95% CI)Subtotals only

    2.1 Antibiotic prophylaxis vs control/placebo
289Risk Ratio (M-H, Random, 95% CI)1.32 [0.31, 5.60]

    2.2 Cephazolin vs other antibiotic
14Risk Ratio (M-H, Random, 95% CI)0.83 [0.28, 2.51]

 3 Infections in burned people (pneumonia)1Risk Ratio (M-H, Random, 95% CI)Totals not selected

    3.1 Cephazolin vs other antibiotic
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 4 Infections in burned people (urinary tract infection)1Risk Ratio (M-H, Random, 95% CI)Totals not selected

    4.1 Cephazolin vs other antibiotic
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 5 Adverse events2Risk Ratio (M-H, Random, 95% CI)Totals not selected

    5.1 Antibiotic prophylaxis vs control/placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

    5.2 Cephazolin vs other antibiotic
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 6 All-cause mortality1Risk Ratio (M-H, Random, 95% CI)Totals not selected

    6.1 Antibiotic prophylaxis vs control/placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 7 Length of hospital stay (LOS)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    7.1 Antibiotic prophylaxis vs control/placebo
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 4. Non-absorbable antibiotic prophylaxis (selective decontamination of the digestive tract)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Burn wound infection1Risk Ratio (M-H, Random, 95% CI)Totals not selected

    1.1 Non-absorbable antibiotic prophylaxis and cefotaxime vs placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 2 Infections in burned people (sepsis)1Risk Ratio (M-H, Random, 95% CI)Totals not selected

    2.1 Non-absorbable antibiotic prophylaxis vs placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 3 Infections in burned people (bacteraemia)1Risk Ratio (M-H, Random, 95% CI)Totals not selected

    3.1 Non-absorbable antibiotic prophylaxis and cefotaxime vs placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 4 Infections in burned people (pneumonia)2Risk Ratio (M-H, Random, 95% CI)Totals not selected

    4.1 Non-absorbable antibiotic prophylaxis vs placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

    4.2 Non-absorbable antibiotic prophylaxis and cefotaxime vs placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 5 Infections in burned people (urinary tract infection)1Risk Ratio (M-H, Random, 95% CI)Totals not selected

    5.1 Non-absorbable antibiotic prophylaxis and cefotaxime vs placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 6 Adverse events1Risk Ratio (M-H, Random, 95% CI)Totals not selected

    6.1 Non-absorbable antibiotic prophylaxis vs placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 7 Antibiotic resistance (MRSA)1Risk Ratio (M-H, Random, 95% CI)Totals not selected

    7.1 Non-absorbable antibiotic prophylaxis and cefotaxime vs placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 8 All-cause mortality2Risk Ratio (M-H, Random, 95% CI)Subtotals only

    8.1 Non-absorbable antibiotic prophylaxis vs placebo
123Risk Ratio (M-H, Random, 95% CI)2.18 [0.23, 20.84]

    8.2 Non-absorbable antibiotic prophylaxis and cefotaxime vs placebo
1107Risk Ratio (M-H, Random, 95% CI)0.34 [0.13, 0.87]

 9 Length of hospital stay (LOS)2Mean Difference (IV, Fixed, 95% CI)Subtotals only

    9.1 Non-absorbable antibiotic prophylaxis vs placebo
123Mean Difference (IV, Fixed, 95% CI)7.0 [3.28, 10.72]

    9.2 Non-absorbable antibiotic prophylaxis and cefotaxime vs placebo
1107Mean Difference (IV, Fixed, 95% CI)-1.70 [-15.82, 12.42]

 
Comparison 5. Local antibiotic prophylaxis (airway)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Infections in burned people (sepsis)1Risk Ratio (M-H, Random, 95% CI)Totals not selected

    1.1 Antibiotic prophylaxis vs control/placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 2 All-cause mortality1Risk Ratio (M-H, Random, 95% CI)Totals not selected

    2.1 Antibiotic prophylaxis vs control/placebo
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 
Comparison 6. Antibiotic prophylaxis vs control/placebo

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Burn wound infection7554Risk Ratio (M-H, Random, 95% CI)0.84 [0.51, 1.39]

    1.1 Topical antibiotic prophylaxis
299Risk Ratio (M-H, Random, 95% CI)0.81 [0.47, 1.39]

    1.2 Systemic antibiotic prophylaxis (general)
279Risk Ratio (M-H, Random, 95% CI)0.64 [0.07, 6.09]

    1.3 Systemic antibiotic prophylaxis (perioperative)
2269Risk Ratio (M-H, Random, 95% CI)0.51 [0.03, 7.37]

    1.4 Non-absorbable antibiotic prophylaxis (selective decontamination of the digestive tract)
1107Risk Ratio (M-H, Random, 95% CI)0.93 [0.43, 2.00]

 2 Infections in burned people (sepsis)6231Risk Ratio (M-H, Random, 95% CI)1.06 [0.54, 2.10]

    2.1 Topical antibiotic prophylaxis
299Risk Ratio (M-H, Random, 95% CI)7.58 [0.44, 130.38]

    2.2 Systemic antibiotic prophylaxis (general)
279Risk Ratio (M-H, Random, 95% CI)0.43 [0.12, 1.61]

    2.3 Non-absorbable antibiotic prophylaxis (selective decontamination of the digestive tract)
123Risk Ratio (M-H, Random, 95% CI)2.18 [0.49, 9.65]

    2.4 Local antibiotic prophylaxis (airway)
130Risk Ratio (M-H, Random, 95% CI)1.04 [0.67, 1.60]

 3 Infections in burned people (bacteraemia)5313Risk Ratio (M-H, Random, 95% CI)1.08 [0.67, 1.72]

    3.1 Topical antibiotic prophylaxis
166Risk Ratio (M-H, Random, 95% CI)0.4 [0.08, 1.92]

    3.2 Systemic antibiotic prophylaxis (general)
151Risk Ratio (M-H, Random, 95% CI)3.12 [0.13, 73.06]

    3.3 Systemic antibiotic prophylaxis (perioperative)
289Risk Ratio (M-H, Random, 95% CI)1.32 [0.31, 5.60]

    3.4 Non-absorbable antibiotic prophylaxis (selective decontamination of the digestive tract)
1107Risk Ratio (M-H, Random, 95% CI)1.14 [0.67, 1.94]

 4 Infections in burned people (pneumonia)4203Risk Ratio (M-H, Random, 95% CI)0.54 [0.17, 1.74]

    4.1 Topical antibiotic prophylaxis
133Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

    4.2 Systemic antibiotic prophylaxis (general)
140Risk Ratio (M-H, Random, 95% CI)0.18 [0.05, 0.72]

    4.3 Non-absorbable antibiotic prophylaxis (selective decontamination of the digestive tract)
2130Risk Ratio (M-H, Random, 95% CI)0.73 [0.46, 1.16]

 5 Infections in burned people (urinary tract infection)2158Risk Ratio (M-H, Random, 95% CI)0.43 [0.18, 1.00]

    5.1 Systemic antibiotic prophylaxis (general)
151Risk Ratio (M-H, Random, 95% CI)0.35 [0.01, 8.12]

    5.2 Non-absorbable antibiotic prophylaxis (selective decontamination of the digestive tract)
1107Risk Ratio (M-H, Random, 95% CI)0.44 [0.18, 1.05]

 6 Infection-related mortality2Risk Ratio (M-H, Random, 95% CI)Subtotals only

    6.1 Systemic antibiotic prophylaxis (general)
279Risk Ratio (M-H, Random, 95% CI)0.27 [0.05, 1.58]

 7 Adverse events4340Risk Ratio (M-H, Random, 95% CI)3.12 [1.22, 7.97]

    7.1 Systemic antibiotic prophylaxis (general)
268Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

    7.2 Systemic antibiotic prophylaxis (perioperative)
1249Risk Ratio (M-H, Random, 95% CI)0.96 [0.06, 15.19]

    7.3 Non-absorbable antibiotic prophylaxis (selective decontamination of the digestive tract)
123Risk Ratio (M-H, Random, 95% CI)3.64 [1.34, 9.86]

 8 Antibiotic resistance (MRSA)3180Risk Ratio (M-H, Random, 95% CI)0.66 [0.12, 3.73]

    8.1 Topical antibiotic prophylaxis
133Risk Ratio (M-H, Random, 95% CI)0.56 [0.11, 2.90]

    8.2 Systemic antibiotic prophylaxis (general)
140Risk Ratio (M-H, Random, 95% CI)0.13 [0.02, 0.96]

    8.3 Non-absorbable antibiotic prophylaxis (selective decontamination of the digestive tract)
1107Risk Ratio (M-H, Random, 95% CI)2.22 [1.21, 4.07]

 9 All-cause mortality7348Risk Ratio (M-H, Random, 95% CI)0.62 [0.39, 0.99]

    9.1 Systemic antibiotic prophylaxis (general)
3119Risk Ratio (M-H, Random, 95% CI)0.41 [0.17, 1.02]

    9.2 Systemic antibiotic prophylaxis (perioperative)
169Risk Ratio (M-H, Random, 95% CI)1.62 [0.42, 6.25]

    9.3 Non-absorbable antibiotic prophylaxis (selective decontamination of the digestive tract)
2130Risk Ratio (M-H, Random, 95% CI)0.64 [0.11, 3.61]

    9.4 Local antibiotic prophylaxis (airway)
130Risk Ratio (M-H, Random, 95% CI)0.75 [0.39, 1.44]

 10 Length of hospital stay (LOS)5463Mean Difference (IV, Fixed, 95% CI)-0.18 [-1.27, 0.91]

    10.1 Topical antibiotic prophylaxis
133Mean Difference (IV, Fixed, 95% CI)-3.67 [-9.46, 2.12]

    10.2 Systemic antibiotic prophylaxis (general)
151Mean Difference (IV, Fixed, 95% CI)0.80 [-1.47, 3.07]

    10.3 Systemic antibiotic prophylaxis (perioperative)
1249Mean Difference (IV, Fixed, 95% CI)-1.28 [-2.64, 0.08]

    10.4 Non-absorbable antibiotic prophylaxis (selective decontamination of the digestive tract)
2130Mean Difference (IV, Fixed, 95% CI)6.43 [2.84, 10.03]

 
Table 1. Definition of the outcomes assessed

Study-YearWound infectionSepsisBacteraemiaPneumoniaUrinary tract infectionAdverse events Time to complete healing 

Alexander 1982 Discharge of pus in the graft site, associated with graft loss. 

     
 

     
 

     
 

     
Any adverse event related to the administration of the antibiotic or the placebo.  

     

Alexander 1984 

     
 

     
Did not define bacteraemia, but assessed the total number of episodes of bacteraemia per days at risk 

     
 

     
 

     
 

     

Ang 2001 Clinical evaluation (presence of fever and/or redness of the wound) and qualitative bacteriological examination of samples from the wound. 

     
Bacterial infection was evaluated by bacteriological examination of blood.Presence of respiratory infection was determined by qualitative bacteriological examination of sputum.Determined the presence of urinary tract infection by qualitative bacteriological examination of urine. 

     
Wound was declared healed when 75% of the total surface had healed.

Barret 2000Determined BWI through the assessment of clinical data. 

     
Did not define bacteraemia, but reported data on this result. 

     
 

     
 

     
Defined wound cicatrisation as closing of all affected areas in the initial wound.

Barret 2001Burn wound biopsy with more than 105 organism/g
tissue and/or histologic evidence of viable tissue
invasion.
Presence of a septic source: (1) burn wound biopsy with more than 105 organism/g
tissue and/or histologic evidence of viable tissue
invasion, (2) positive blood culture, (3) urinary tract infection with 105 organism/ml urine; and (4) pulmonary infection with positive bacteria and white
cells on a class III, or better sputum specimen.

In addition to the identification of a septic source, five or more of the following criteria had to be met: tachypnoea
(> 40 breaths/minute); prolonged paralytic ileus;
hyper- or hypothermia (< 36.5°C or > 38.5°C); altered
mental status; thrombocytopenia (< 50 000 platelets/mm3); leucocytosis or leukopenia (< 3.5 or > 15.0 cells/mm3); unexplained acidosis; or hyperglycaemia.
 

     
Pulmonary infection with positive bacteria and white
cells on a class III, or better sputum specimen.
 

     
Did not define adverse events, but registered diverse complication.Did not define cicatrisation, but reported time to complete healing.

Bugmann 1998Did not define BWI, but reported data on this result. 

     
 

     
 

     
 

     
Reported allergies and bleeding as adverse events.A wound was considered cicatrised when it had healed completely.

Caruso 2006Did not define BWI, but reported data on this result. 

     
      

     
 

     
Any new adverse event (including infection) or any adverse event that had worsened during the study.A wound was considered cicatrised when there was 100% re-epithelisation, including the small residual crusts, blisters and open areas of < 1 cm in an area that had been re-epithelialized completely.   

De La Cal 2005BWI determined by microbiological testing of samples from the surface of the wound, performed upon admission and then twice a week. 

     
Bloodstream infections
were diagnosed according to CDC definitions for nosocomial
infections.
Presence of new (or
progressive) pulmonary infiltrates persisting for > 48 h on chest X-ray, in addition to at least 2 of the following
criteria: (1) fever ≥ 38.5°C or hypothermia < 35.0°C; (2) leucocytosis ≥ 10,000/mm3 or leukopenia < 3000/mm3;
(3) isolation of potential pathogens in high concentration of
≥ 4 x 107 cfu/ml using semi quantitative
culture, from unprotected purulent tracheal aspirates.
Urinary tract infections
were diagnosed according to CDC definitions for nosocomial
infections.
 

     
 

     

Demling 1999BWI determined by clinical assessment of signs (increased exudate and surrounding cellulitis). 

     
 

     
 

     
 

     
 

     
Determined that the wounds were healed when re-epithelialization had reached ≥ 90%.

Demling 2003 Accepted quantitative culture of samples from the wound as evidence of infection. 

     
 

     
 

     
 

     
 

     
Determined that the wounds were healed when re-epithelialization had reached 95%.

Desai 1991 Determined BWI through the clinical evaluation of signs and symptoms.   

     
 

     
 

     
 

     
 

     
 

     

Durtschi 1982 Wound infection was considered when had cellulitis. The cellulitis was clinically defined as an area of warm, spreading, cutaneous erythema, accompanied by local pain and fever. Cellulite was determined by positive culture of samples from the surface of the wound.

The samples for the culture were taken upon admission, and the samples for follow-up, at days 5 and 7. 
Syndrome resulting from the presence
of > 100,000 organisms/g biopsied wound tissue, associated with variable temperature and
leucocyte count, blood chemistry abnormalities, and occasionally - but not invariably - accompanied by positive blood cultures.
Did not define bacteraemia, but reported data on bacteraemia by beta-haemolytic streptococcal. 

     
Did not define urinary tract infection, but reported data on this outcome. 

     
 

     

Fisher 1968Determined that the presence of "local purulence" constituted infection. Additionally, accepted a positive bacterial culture of wound samples as proof of infection.Did not define the term sepsis, but reported patients who had presented with purulence with septicaemia.Presence of systemic disease. 

     
 

     
 

     
Did not define cicatrisation, but reported time to healing.

Gerding 1988 Infection determined by semi-quantitative cultures of surface samples. 

     
 

     
 

     
 

     
 

     
Completely re-epithelialized wounds. Wounds considered to be treatment failures if had not healed within 21  days or had required skin grafts.

Gerding 1990Did not define BWI, but reported data on this outcome. 

     
 

     
 

     
 

     
 

     
Healing time defined as the time required to achieve full epithelialisation of the burned surface.

Glat 2009 Determined BWI through the assessment of clinical data. 

     
 

     
 

     
 

     
Did not define adverse events, but reported data on possible adverse effects. 

     

Gong 2009 Infection determined by semi-quantitative cultures of wound surface samples. 

     
 

     
 

     
     Did not define adverse events, but reported data on adverse reactions.Did not report the definition of cicatrisation, but assessed the percentage of wound healing at different times, up to 21 days and to the time healing. 

Gotschall 1998 BWI defined by the presence of clinical data in conjunction with cultures from the wound surface. 

     
 

     
 

     
 

     
 

     
Did not define cicatrisation, but reported time to healing.

Hauser 2007 Infection determined by semi-quantitative cultures of wound surface samples. 

     
 

     
 

     
 

     
 

     
Determined that the wounds were healed when re-epithelialization had reached 95%-100%.

Hosseini 2009 Determined BWI through the assessment of clinical data. 

     
 

     
 

     
 

     
 

     
 

     

Kimura 1998  

     
 

     
 

     
Patients satisfying all of the following criteria: (1) infiltration of lung fields on chest X-ray films;
(2) fever (> 38°C) for at least 3 consecutive days;

(3) peripheral
white blood cell count > 104/mm3.

(4) Pathogenic
bacteria (> 103 cfu/ml) detected in airway
secretions.
 

     
Did not define adverse events, but assessed the associated secondary effects during the period of antibiotic administration. 

     

Khorasani 2009 

     
 

     
 

     
Did not define urinary tract infection but reported data on this outcome.

 

     
     Determined by clinical assessment

of the wound

(assessment of the nature of epithelialization - percentage and healing time). 

 

Levine 1978  

     
Did not define sepsis, but reported that blood cultures were performed three times a week and upon suspicion of sepsis. 

     
 

     
 

     
 

     
 

     

Livingston 1990More than 105 organisms/g of
tissue in both the nonadherent graft and recipient
site.
Did not define sepsis, but reported data on this outcome. 

     
      

     
 

     
 

     

Maya 1986 BWI determined by daily assessment of signs and symptoms. 

     
 

     
 

     
 

     
 

     
 

     

Miller 1987Defined wound infection as cellulitis.

Bacterial cultures were performed when there was suspicion of infection and at the end of the study.
 

     
 

     
Did not define pneumonia, but reported data on this outcome.Did not define urinary tract infection, but reported data on this outcome. Conducted routine urine analysis.Did not define adverse events, but reported data on adverse reactions. 

     

Mohammadi 2009Defined wound infection through the  daily evaluation of signs and symptoms.When there were symptoms and signs of hypothermia,
hypotension, abrupt hyperglycaemia, decreased urine output, thrombocytopenia and diet intolerance, a thorough check-up including blood culture and urine culture was done.
 

     
 

     
 

     
 

     
 

     

Moharamzad 2010Did not define BWI, but reported data on this outcome. 

     
 

     
 

     
 

     
 

     
Did not define cicatrisation, but reported data on time to healing.

Muangman 2006Determined wound infection by clinical data in conjunction with cultures from the wound surface.

 
      

     
 

     
 

     
 

     
 

     

Munster 1986Presence of clinical data together with burn wound biopsy with > 105 organisms/g
tissue. Biopsies were taken twice a week.
Determined sepsis through two parameters: (1) presence of a positive blood culture, and the presence or absence of standard signs of sepsis such as hypothermia, disorientation and paralytic ileus; or (2) presence of a quantitative biopsy on one or more occasions of ≥ 105 organisms coupled with any of the clinical parameters mentioned above. 

     
 

     
 

     
Did not define adverse events, but reported data on possible adverse effects. 

     

Noordenbos 1999Did not define BWI, but reported data on this outcome. 

     
 

     
 

     
 

     
 

     
Determined that wounds were healed when there had been epithelial closing of 90% of the site of the wound.

Rodgers 1997BWI determined by quantitative culture of tissue biopsies. Performed colony count; results expressed as cfu/g of tissue.

A culture was considered positive when growth was more than 105 cfu/g of tissue. 
 

   
Did not define bacteraemia, but reported data on this outcome. Blood cultures were performed for the isolation and identification of pathogenic organisms. 

     
 

     
 

     
 

     

Silver 2007Did not define BWI, but reported data on this outcome. 

     
 

     
 

     
 

     
Did not define adverse events, but reported data on possible adverse effects. 

     

Soroff 1994 

     
 

     
 

     
 

     
 

     
Did not define adverse events, but reported data on this outcome.Determined that the wounds were healed when there was a new layer of epithelium.

Subrahmanyam 1998Presence of burn wound biopsy with > 105 organisms/g
tissue.
 

     
 

     
 

     
 

     
 

     
 

     

 Tayade 2006 Defined wound infection through the  evaluation of clinical data. 

     
 

     
 

     
 

     
Any adverse effects related to medication (allergic or hypersensitivity reactions) or a worsening of symptoms or complications (infection, wound infection).Did not define cicatrisation, but reported data on time to healing.

 Abbreviations
< = less than
> = more than
≥ = more than or equal to
BWI = burn wound infection
CDC = Centers for Disease Control
cfu = colony forming units
h = hour(s)
 
Table 2. Time to complete wound healing

Study or SubgroupAntibioticControlP valueHazard Ratio

(HR)


MeanSDNMeanSDN

Neomycin, bacitracin and polymyxin B vs control/placebo

Fisher 196822.03324.033

Silver sulfadiazine vs polymyxin B/bacitracin

Soroff 199415.020.31510.04.615P value 0.0007

Silver sulfadiazine vs dressings (skin substitute)

Barret 200016.10.6109.70.710P value < 0.001

Bugmann 199811.266.02357.583.1241P value < 0.01

Caruso 200617.04216.042P value 0.517

Gerding 198821.32.32313.71.327P value < 0.01

Gerding 199015.01.22610.60.830P value < 0.01

Gong 200917.34.565213.13.552P value < 0.05

Gotschall 199827.63010.533P value 0.0002

Noordenbos 199918.16.051411.14.3714P value 0.002

Tayade 200618.442512.6425

Silver sulfadiazine vs any topical preparation of natural products (traditional medicine)

Ang 200120.05817.057P value 0.110.67

Khorasani 200918.732.653015.92.030P value < 0.0001

Moharamzad 20109.73.55512.81.856P value < 0.05

Topical antibiotic prophylaxis vs other treatments

Fisher 196822.03323.033

Hauser 200711.34.9479.94.547P value 0.015

Other topical antibiotics vs dressings (skin substitute)

Demling 199913.03.5118.01.510P value < 0.05

Demling 200310.5208.524P value < 0.05

Non-absorbable antibiotic prophylaxis vs placebo

Barret 200140.08.01133.04.012

 Abbreviations
< = less than
vs = versus