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Topical treatment for facial burns

  1. Cornelis J Hoogewerf1,
  2. Margriet E Van Baar1,*,
  3. M Jenda Hop1,
  4. Marianne K Nieuwenhuis2,
  5. Irma MMH Oen1,
  6. Esther Middelkoop3

Editorial Group: Cochrane Wounds Group

Published Online: 31 JAN 2013

Assessed as up-to-date: 9 NOV 2012

DOI: 10.1002/14651858.CD008058.pub2


How to Cite

Hoogewerf CJ, Van Baar ME, Hop MJ, Nieuwenhuis MK, Oen IMMH, Middelkoop E. Topical treatment for facial burns. Cochrane Database of Systematic Reviews 2013, Issue 1. Art. No.: CD008058. DOI: 10.1002/14651858.CD008058.pub2.

Author Information

  1. 1

    Association of Dutch Burn Centres, Burn Centre, Maasstad Hospital, Rotterdam, South-Holland, Netherlands

  2. 2

    Association of Dutch Burn Centres, Burn Centre, Martini Hospital, Groningen, Groningen, Netherlands

  3. 3

    Association of Dutch Burn Centres, Burn Centre, Red Cross Hospital, Beverwijk, North-Holland, Netherlands

*Margriet E Van Baar, Burn Centre, Maasstad Hospital, Association of Dutch Burn Centres, PO Box 9100, Rotterdam, South-Holland, 3007 AC, Netherlands. baarm@maasstadziekenhuis.nl.

Publication History

  1. Publication Status: New
  2. Published Online: 31 JAN 2013

SEARCH

 
Characteristics of included studies [ordered by study ID]
Ang 2000

MethodsRCT.


Participants39 participants (17 intervention, 22 control) with partial-thickness burns up to 40% BSA burned and suffering facial burns.
Exclusion criteria: > 40% BSA burned, extremes of age (< 6 years and > 80 years), chemical and electrical burns, no facial burns.


InterventionsTreatment intervention: Moist Exposed Burn Ointment (MEBO), 1 mm thick layer applied 6 times/day.
Control intervention: SSD applied 2 times/day.


OutcomesNumber of days for the face wound to heal.
Number of participants completely healed in 10 days.
Number of participants requiring reconstructive surgery within 6 months post-burn.


NotesParticipants were a subgroup of a larger study conducted by Ang et al (Ang 2001). That study included not only facial burns but also burns to other locations. 3 participants were excluded from this study: 1 withdrew, 1 was an illegal worker and 1 had a TBSA burned of 68% - not clear whether these participants had facial burns. Also, in this study, 2 participants in the control group died at 36 and 49 days post-burn. These two participants were included in Ang 2000, therefore, the number of participants in the long-term analyses was 20 instead of 22. The short-term analysis was not affected.

Sponsorship: Quote: "None of the investigators had any financial interest in or received any benefits or privileges from the company manufacturing MEBO".


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "patients were randomly assigned either to the conventional (C) group or MEBO group either by telephone calls to the NMRC Clinical Trials and Epidemiology Research Unit, Singapore during office hours, or by sealed envelopes after office hours. Randomly alternating permuted sub-blocks of size 4 and 6, with equal numbers per treatment within each sub-block, were used to obtain an overall block size of 10".

Allocation concealment (selection bias)Low riskQuote: "patients were randomly assigned either to the conventional (C) group or MEBO group either by telephone calls to the NMRC Clinical Trials and Epidemiology Research Unit, Singapore during office hours, or by sealed envelopes after office hours. Randomly alternating permuted sub-blocks of size 4 and 6, with equal numbers per treatment within each sub-block, were used to obtain an overall block size of 10".

Comment: Probably done, although not stated explicitly that envelopes were opaque.

Blinding (performance bias and detection bias)
All outcomes - patients
High riskNot possible, frequency and appearance of treatments were different.

Blinding (performance bias and detection bias)
All outcomes - care provider
High riskNot possible, frequency and appearance of treatments were different.

Blinding (performance bias and detection bias)
All outcomes - outcome assessor
Low riskThis article used a subgroup. In Ang 2001 the whole population was used and "a burn surgeon not involved in management of cases" assessed the outcomes. Therefore, the judgement is one of low risk of bias.

Incomplete outcome data (attrition bias)
All outcomes - drop-out rate?
Low risk3 drop-outs in the intervention group that were eligible for inclusion (n = 57), but unclear if the drop-outs had facial burns.

Incomplete outcome data (attrition bias)
All outcomes - ITT analysis?
High riskDrop-outs were not analysed.

Selective reporting (reporting bias)Low riskOutcomes listed in methods were described in results.

Comment: Not seen protocols.

Similarity of baseline characteristics?Unclear riskOnly one characteristic was described (mean % TBSA burned).

Co-interventions avoided or similar?High riskCo-interventions varied, with different cleaning methods for the different treatments in Ang 2001.

Comment: Since the participants in Ang 2000 were a subgroup from the participants in Ang 2001, it is likely that the co-interventions were different.

Compliance acceptable?Low riskNot mentioned explicit, but likely.

Timing outcome assessments similar?Low riskAfter 5 days, then every 3 days until discharge for both groups.

Demling 1999

MethodsRCT.


Participants21 participants (10 intervention, 11 control) > 18 years with partial-thickness (mid-dermal) burns of at least 50% of the facial surface.
Exclusion criteria: < 18 years, < 50% of facial surface burned, no partial-thickness burns.


InterventionsTreatment intervention: biological skin substitute coated with fibronectin (TransCyte).
Control intervention: topical antibiotics (bacitracin).


OutcomesTime to complete wound healing (> 90% re-epithelialisation).
Wound infection.
Pain (0-10 scale, 0 lowest and 10 highest).
Length of hospital stay.


NotesSponsorship: Authors used TransCyte, unclear if this was sponsored or purchased.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomisation stated, but nothing mentioned about sequence generation.

Allocation concealment (selection bias)Unclear riskRandomisation stated, but nothing mentioned about allocation concealment.

Blinding (performance bias and detection bias)
All outcomes - patients
High riskNot possible due to different appearances of treatments.

Blinding (performance bias and detection bias)
All outcomes - care provider
High riskNot possible due to different appearances of treatments.

Blinding (performance bias and detection bias)
All outcomes - outcome assessor
High riskBurn nurse was not blinded to the intervention.

Incomplete outcome data (attrition bias)
All outcomes - drop-out rate?
Unclear riskNot reported.

Incomplete outcome data (attrition bias)
All outcomes - ITT analysis?
Unclear riskNot reported.

Selective reporting (reporting bias)Low riskOne prespecified outcome, length of hospital stay, was not reported for the major burns group. In this group, the outcome was insignificant due to interference from other burns that lengthened the hospital stay.

Similarity of baseline characteristics?Low riskSubgroups were similar, described in Tables 1 & 2.

Co-interventions avoided or similar?Low riskSome participants in the control group were treated with 2 antimicrobials, some participants only with bacitracin. These are still topical interventions.

Compliance acceptable?Low riskNot mentioned explicitly, but likely.

Timing outcome assessments similar?Low riskDaily assessment.

Demling 2002

MethodsRCT.


Participants34 participants (16 intervention, 18 control) with major burns including partial-thickness facial burns at least mid-dermal in depth.
Exclusion criteria: superficial partial-thickness burns.


InterventionsTreatment intervention: bioactive skin substitute (a bilayered, biologically active, temporary skin substitute (TransCyte)).
Control intervention: antibacterial ointment, no further details available.


OutcomesTime to complete wound healing (> 95% re-epithelialisation).
Wound infection.
Pain (0-10 scale, 0 lowest and 10 highest).


NotesSponsorship: Used: TransCyte®, Smith & Nephew, Inc., Largo, Florida.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomisation stated, but nothing mentioned about sequence generation.

Allocation concealment (selection bias)Unclear riskRandomisation stated, but nothing mentioned about allocation concealment.

Blinding (performance bias and detection bias)
All outcomes - patients
High riskNot possible due to different appearances of treatments.

Blinding (performance bias and detection bias)
All outcomes - care provider
High riskNot possible due to different appearances of treatments.

Blinding (performance bias and detection bias)
All outcomes - outcome assessor
High riskBurn nurse was not blinded to the intervention.

Incomplete outcome data (attrition bias)
All outcomes - drop-out rate?
Low riskNo drop-outs.

Incomplete outcome data (attrition bias)
All outcomes - ITT analysis?
Low riskNot reported, but likely.

Selective reporting (reporting bias)Low riskOutcomes in methods section were described in results section.

Similarity of baseline characteristics?Low riskSubgroups were similar, described in  Table 1.

Co-interventions avoided or similar?Unclear risk"Subsequent care in intervention group when needed", not reported how often.

Compliance acceptable?Low riskNot mentioned explicitly, but likely.

Timing outcome assessments similar?Low riskDaily assessment.

Desai 1991

MethodsRCT.


Participants15 participants (7 intervention, 8 control) with ear burns admitted within 72 hours of burn injury.
Exclusion: no informed consent, < 5 years old, not responding to tactile stimulation, not able to communicate discomfort verbally.


InterventionsTreatment intervention: gentamicin iontophoresis + routine care (mafenide acetate).
Control intervention: routine care only (6-hourly application of mafenide acetate).


OutcomesWound infection.
Need for (reconstructive) surgery.
Adverse effects of treatment.
Length of hospital stay.


NotesSponsorship: Not stated. Although sponsorship seems unlikely, still unclear.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Subjects were randomly assigned."

Comment: No method of sequence generation described.

Allocation concealment (selection bias)Unclear riskQuote: "Subjects were randomly assigned."

Comment: No method of allocation concealment described.

Blinding (performance bias and detection bias)
All outcomes - patients
High riskNature of intervention made blinding impossible.

Blinding (performance bias and detection bias)
All outcomes - care provider
High riskNature of intervention made blinding impossible.

Blinding (performance bias and detection bias)
All outcomes - outcome assessor
Unclear riskNot stated who assessed the outcomes.

Incomplete outcome data (attrition bias)
All outcomes - drop-out rate?
Unclear riskNo drop-out rate described.

Incomplete outcome data (attrition bias)
All outcomes - ITT analysis?
Unclear riskNot stated, unable to confirm.

Selective reporting (reporting bias)High riskWound healing listed as outcome, but no results presented.

Similarity of baseline characteristics?High riskOnly age, % full thickness burns and time since burn. Not similar with regard to % TBSA burned. Etiology was not mentioned.

Co-interventions avoided or similar?Unclear riskNot stated.

Compliance acceptable?Low riskNot mentioned explicitly, but likely.

Timing outcome assessments similar?Low riskDaily evaluation of infection. Timing of other outcomes was until closure of ear burns.

Horch 2005

MethodsRCT.


Participants10 severely burned participants (5 intervention, 5 control) with superficial and deep partial-thickness facial burns.
Exclusion criteria: superficial partial-thickness burns or third-degree facial burns.


InterventionsTreatment intervention: glycerolised allograft cadaver (corpse) skin.
Control intervention: open treatment with SSD ointment.


OutcomesTime to complete wound healing.
Wound infection.
Scar quality.
Adverse effects.


NotesSponsorship: Not reported.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "were randomized into groups"

Comment: No method of sequence generation described.

Allocation concealment (selection bias)Unclear riskQuote: "were randomized into groups"

Comment: No method of allocation concealment described.

Blinding (performance bias and detection bias)
All outcomes - patients
High riskNot possible due to different appearances of treatments.

Blinding (performance bias and detection bias)
All outcomes - care provider
High riskNot possible due to different appearances of treatments.

Blinding (performance bias and detection bias)
All outcomes - outcome assessor
Unclear riskNot evident who assessed the outcome.

Incomplete outcome data (attrition bias)
All outcomes - drop-out rate?
Low riskNo drop-outs.

Incomplete outcome data (attrition bias)
All outcomes - ITT analysis?
Low riskNot reported, but likely.

Selective reporting (reporting bias)Low riskOutcomes listed in methods section were described in results section.

Similarity of baseline characteristics?Low riskStated similar, but not possible to check.

Co-interventions avoided or similar?Unclear riskNot reported.

Compliance acceptable?Low riskNot mentioned explicitly, but likely.

Timing outcome assessments similar?Low riskIncidence of hypertrophic scar formation at 6 months post-burn.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Ang 2001Facial burns not distinguishable from other burns. The participants with facial burns were described in a previous study (Ang 2000), which was included in this review.

Branski 2008Not a randomised controlled trial. After personal communication, this study was judged to be a CCT because allocation was not concealed as every other patient eligible for this trail received amnion.

Covey 1987In the absence of the abstract, this study was included on the basis of the title only. After judging full text it was decided that this was not an RCT.

Hartmann 2007Not an RCT.

Lansdown 2004Not an RCT.

Li 2005Not an RCT.

Liang 2007Not an RCT.

Papp 1990Not an RCT.

Rege 1999No facial burns.

 
Characteristics of studies awaiting assessment [ordered by study ID]
Hindy 2009

MethodsRCT.

Participants60 participants with superficial dermal burns to the face.

InterventionsGroup 1: Sodium carboxymethyl-cellulose silver (Aquacel Ag®).

Group 2: Moist Exposed Burn Ointment (MEBO®).

Group 3: Saline soaked dressing.

OutcomesTime necessary for healing.

Pain.

Quality of healing.

Patient satisfaction.

NotesStudy was identified in latest search update. Full text is not yet assessed.

Jiaao 2011

MethodsRCT.

Participants30 children.

InterventionsTreatment intervention: rhGM-CSF hydrogel.

Control intervention: placebo hydrogel.

OutcomesPercentage of wound healing.

Time to complete wound healing.

Adverse effects.

NotesStudy was identified in latest search update. Full text is not yet assessed.

Mabrouk 2012

MethodsRCT.

Participants40 participants with partial-thickness facial burns.

InterventionsIntervention 1: occlusive dressing (Aquacel Ag®).

Intervantion 2: Moist Exposed Burn Ointment (MEBO®).

OutcomesLenght of hospital stay.

Rate of infection.

Time to total healing.

Frequency of dressing changes.

Pain.

Cost benefit.

Patient discomfort.

Incidence of hypertrophic scarring.

NotesStudy was identified in latest search update. Full text is not yet assessed.

Oen 2012

Methods"A Randomized Multicentre Clinical Trial".

Participants180 participants of 18 years of age or older, competent or temporarily incompetent, admitted to one of the 3 dedicated Dutch Burn Centres with burn injuries involving the face.
Exclusion criteria: not seen within 24 hours post-burn, mental or cognitive deficits that may interfere with providing informed consent, poor proficiency in Dutch, chemical burns.

InterventionsIntervention 1: cerium nitrate SSD (flammacerium).
Intervention 2: silver sulphadiazine (SSD) (flammazine).

OutcomesNumber of participants requiring surgical excision of their facial burns.
Quality of life and self esteem.
Quality of scar.
Scar elasticity, vascularisation and pigmentation.
Hypertrophic surface area.

NotesStudy was identified in latest search update. Full text is not yet assessed.

 
Characteristics of ongoing studies [ordered by study ID]
Lehna 2012

Trial name or titleComparison of wound bed establishment in facial burns.

MethodsRCT.

Participants30 participants of 18 years of age or older, admitted to the burn unit with a minimum of 1% partial-thickness burns each side of the face.

InterventionsCollagenase versus Bacitracin.

OutcomesDifference in wound bed establishment; pain; anxiety; itch levels; wound healing.

Starting dateApril 2012.

Contact informationc0lehn01@louisville.edu

Notes

 
Comparison 1. MEBO vs silver sulphadiazine (SSD)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Proportion completely healed in 10 days1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Comparison 2. Gentamicin iontophoresis vs routine care

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Chondritis1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 2 Gentamicin-resistant micro-organisms1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 3 Length of hospital stay in days1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 
Comparison 3. Bioengineered skin substitute vs topical antibiotic

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Pain in minor burns during facial care1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 2 Pain in minor burns between facial care1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 3 Pain in major burns during facial care1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 4 Pain in major burns between facial care1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 5 Pain during facial care1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 6 Pain between facial care1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 7 Length of hospital stay in days1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 
Comparison 4. Biological skin substitute vs SSD

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Hypertrophic scar formation1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Table 1. Results from included trials

Study IDMain baseline characteristicsNumber of participants and drop-out ratePrimary outcomesSecondary outcomes

Ang 2000Number of participants:

I: 17; C: 22.

% TBSA burned (Mean; SE; Range):

I: 2.16; 0.38; 0.13-6.0:
C: 1.56; 0.18; 0.5-3.5.
Initial number of participants: 115.

After randomisation: I: 57; C: 58.

Drop-outs:I: 3; C: 0.

Participants with facial burns: I: 17; C:22.

Particpants in short term analysis:

I: 17; C: 22.

Participants in long term analysis:

I:17; C: 20.
Number of days taken for face-wound to heal:

I: 2-35 days (range); C: not reported.

Proportion completely healed in 10 days:

I: 14/17; C: 17/22.
Need for reconstructive surgery 6 months PB:

I: 0/17; C: 0/20.

Demling 1999Number of participants:

Minor burns: I: 5; C: 5.
Major burns: I: 5; C: 6.

Mean age (SD years):

Minor burns: I: 31(8); C: 29(7).
Major burns: I: 44(10); C: 40(8).

Etiology: Flame.

% TBSA burned (Mean (SD)):

Minor burns: I: 10(3); C: 7(2).
Major burns: I: 32(9); C: 30(8).

% TBSA burned Full-thickness (Mean (SD)):

Minor burns: I: 0; C:0.
Major burns: I: 10(3); C: 8(2).
Initial number of participants: 21.

Number of participants with minor burns: 10.

Number of participants with major burns: 11.

After randomisation:

Minor burns: I: 5; C: 5.
Major burns: I: 5; C: 6.

Participants in short term analysis:

Minor burns: I: 5; C: 5.
Major burns: I: 5; C: 6.
Mean number of days to > 90% re-epithelialisation (SD):

Minor burns:
I: 8(1); C: 12(3); significantly different P < 0.05.

Major burns:
I: 8(2); C: 14(4); significantly different P < 0.05.

Signs of local wound infection:

Minor burns: I: 0; C: 0.
Major burns: I: 0; C: 0.
Pain during facial care (Mean (SD)):

Minor burns: I: 2(1); C: 5(1).
Major burns: I: 2(1); C: 5(1).

Pain between facial care (Mean (SD)):

Minor burns: I: 1(0.5); C: 3(2).
Major burns: I: 2(1); C: 4(2).

Mean length of stay (SD):

Minor burns: I: 1(0.5); C: 3(1).
Major burns: Not reported.

Demling 2002Number of participants:I: 16; C: 18.

Mean age (SD):I: 39(9); C: 40(8).

Etiology:

Flame: I: 11; C: 12.
Scald: I: 5; C: 6.

% TBSA burned (Mean (SD)): I: 24(8); C: 21(9).

% TBSA burned Full-thickness (Mean (SD)):
I: 12(7); C: 10(6).
Initial number of participants: 34.

After randomisation:

I: 16; C: 18.

Participants in short term analysis:

I: 16; C: 18.
Mean number of days to > 95% re-epithelialisation (SD):

I: 9(4); C: 15(4); significantly different P < 0.05.

Signs of infection diagnosed with swab cultures exceeding 105 organisms/gram:

I: 0; C: 0.
Pain during facial care (Mean (SD)): I: 3(1); C: 7(2).

Pain between facial care (Mean (SD)): I: 2(1); C: 4(2).

Desai 1991Number of participants: I: 7; C: 8.

Mean age (SE):I: 11.4 (1.2); C: 9.5(1.6).

% TBSA burned (Mean (SE)): I: 35(7); C: 50(6).

% TBSA burned Full-thickness (Mean (SE)):I: 20(9); C: 32(7).
Initial number of participants: 15.

After randomisation: I: 7; C: 8.

Participants in short term analysis: I: 7; C: 8.
Cases of wound infection diagnosed with the occurrence of chondritis: I: 3; C: 4.Mean number (SE) of surgical procedures required: I: 1.2(0.1) C: 1.0(0); significantly different P < 0.05.

Adverse effect of treatment: occurrence of gentamicin-resistant micro-organisms I: 29%; C: 0%.

Mean length of stay (SE): I: 26(1); C: 38(3).

Horch 2005Number of participants: I: 5; C: 5.

Median age (range): I + C: 34.3(24-67).
Initial number of participants: 10.

After randomisation: I: 5; C: 5.

Participants in short term analysis:

I: 5; C: 5.
Median number of days to complete re-epithelialisation:
I:10.5; C: 12.4; significantly different P < 0.05.

Signs of underlying infection: I: 0; C: not reported
Hypertrophic scar formation: I: 0; C: 2.

Adverse effect of treatment: localized partial integration of the biological dressing I: 1; C: 0.

Abbreviations: I = intervention group; C = control group; TBSA = Total Body Surface Area; SE = Standard Error; PB = post-burn; SD = Standard Deviation; P = P value.