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Negative pressure wound therapy for skin grafts and surgical wounds healing by primary intention

  1. Joan Webster1,2,3,*,
  2. Paul Scuffham4,
  3. Karen L Sherriff5,
  4. Monica Stankiewicz6,
  5. Wendy P Chaboyer5

Editorial Group: Cochrane Wounds Group

Published Online: 18 APR 2012

Assessed as up-to-date: 18 NOV 2011

DOI: 10.1002/14651858.CD009261.pub2


How to Cite

Webster J, Scuffham P, Sherriff KL, Stankiewicz M, Chaboyer WP. Negative pressure wound therapy for skin grafts and surgical wounds healing by primary intention. Cochrane Database of Systematic Reviews 2012, Issue 4. Art. No.: CD009261. DOI: 10.1002/14651858.CD009261.pub2.

Author Information

  1. 1

    Royal Brisbane and Women's Hospital, Centre for Clinical Nursing, Brisbane, Queensland, Australia

  2. 2

    Griffith University, NHMRC Centre for Research Excellence in Nursing, Centre for Health Practice Innovation, Griffith Health Institute, Brisbane, Queensland, Australia

  3. 3

    University of Queensland, School of Nursing and Midwifery, Brisbane, Queensland, Australia

  4. 4

    Griffith University, Meadowbrook, Australia

  5. 5

    Griffith University, NHMRC Centre of Research Excellence in Nursing, Brisbane, Queensland, Australia

  6. 6

    Royal Brisbane and Women's Hospital, Specialist Outpatient Department, Herston, Queensland, Australia

*Joan Webster, joan_webster@health.qld.gov.au.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 18 APR 2012

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This is not the most recent version of the article. View current version (07 OCT 2014)

 
Characteristics of included studies [ordered by study ID]
Chio 2010

MethodsStudy design: randomised controlled trial
Ethics and informed consent: ethics approved and consent obtained

Sample size calculation: yes

ITT analysis: patients analysed in groups to which they were assigned but 4 participants, who did not present for follow-up, were not included in the analysis


ParticipantsLocation: Columbus, Ohio, USA
Mean age Group 1: 62.1;Mean age Group 2: 58.1
Inclusion criteria: patients scheduled to undergo radial forearm free flap
Exclusion criteria: none stated


InterventionsAim/s: to evaluate the effectiveness of negative pressure dressings compared with static pressure dressings in the prevention of graft failure
Intervention/s in both groups: "In all subjects, iodine petroleum–impregnated gauze rolls were placed over the skin graft in the inter-tendon spaces, followed by coverage with a sheet of Adaptic nonadherent dressing (Johnson & Johnson, Langhorne, PA).

Dressings in both treatment groups were left in place for a total of six days, after which all dressings were then taken down, and the donor site dressed with Adaptic and circumferential gauze roll for a total of two weeks".

Group 1 (NPD) intervention: "foam specifically designed for use with the negative pressure device (V.A.C. device; KCI, San Antonio, TX) was cut and the arm covered with an occlusive dressing. The vacuum device was attached and activated intraoperatively and set to –125 mmHg with adequate seal verified. No immobilizing splint was used".

Group 2 (SPD) intervention: "a piece of sterile surgical foam cut to size and wrapped in Adaptic dressing was secured over the recipient bed followed by placement of a volar wrist-immobilizing splint".
Study date/s: March 2007 to August 2009


OutcomesMeasures:

  1. Graft failure
  2. Percentage of area of skin graft failure
  3. Adverse events


Validity of measure/s: quantitative measurements of the donor site were accomplished with the aid of a 1 x 1 cm grid transparency, which was laid over the donor site. The exact borders of the skin graft were then traced onto the overlying grid with a permanent marker.

Time points: follow-up at 2 weeks post surgery (N.B. graft failure was also measured at 1 month post surgery but it was unclear if those from the 2-week follow-up had been included in this measure)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskEvidence: Quote "A randomization schedule, created by a biostatistician using a random number generator".

Comment: blocking not mentioned

Allocation concealment (selection bias)High riskEvidence: Quote "We had a list of the randomization schedule, and pts were assigned to either group based on the order of their surgery" (personal, email communication).

Comment: surgeons aware of the next assignment

Blinding of participants and personnel (performance bias)
All outcomes
High riskEvidence for participants: not described

Comment: difference in appearance of dressings made blinding impossible

Evidence for personnel: not described

Comment: difference in appearance of dressings made blinding impossible

Blinding of outcome assessment (detection bias)
All outcomes
High riskEvidence: Quote "Evaluators at the time of the postoperative visits were not blinded as to which treatment arm the subjects belonged".

Comment: correspondence with the author confirmed that "evaluators" were investigators

Incomplete outcome data (attrition bias)
All outcomes
High riskEvidence: Quote"Four subjects 4/54 (all of whom belonged to the NPD group) were lost to the first postoperative follow-up and were thus excluded from final analysis because no postoperative data could be recorded for these subjects. Of the remaining 50 Ss, only 32 patients (16 subjects in SPD group and 16 subjects in NPD group) returned for their second postoperative visit".

Comment: only data from the first postoperative visit has been included

Unequal distribution of 'drop outs' (15% in negative pressure group; 0% in static pressure group)

Selective reporting (reporting bias)Low riskComment: all the pre-specified clinical outcomes are presented in Table 2. Adverse events are reported in the Results section. Measures reflect the aims of the intervention and the pre-defined outcomes. A published protocol was not available.

Other biasLow riskEvidence: the authors report: Quote "Competing interests: None. Sponsorships: None".

Comment: no other potential biases were identified

Dorafshar 2011

MethodsStudy design: randomised controlled trial
Ethics and informed consent: ethics approved and consent obtained

Sample size calculation: yes

ITT analysis: yes


ParticipantsLocation: University of Chicago Medical Center, IL, USA
Mean age Group 1: 53;Mean age Group 2: 54
Inclusion criteria: patients admitted to University of Chicago Medical Center,18 years of age, with acute wounds resulting from trauma, dehiscence, or surgery
Exclusion criteria:

Systemic sepsis caused by wound infection
Grossly necrotic wounds
Malignancy in the wound
Wounds with untreated osteomyelitis
Patients with allergy to sulfamylon and Dakin’s (sodium hypochlorite) solution
Patients with severe peripheral vascular disease


InterventionsAim/s: Quote "The primary objective was to compare the efficacy of VAC and GSUC with respect to changes in wound size. Secondary objectives were to compare associated costs of the dressings, the ease of application, and the pain associated with each dressing change".
Intervention/s in both groups: Quote "Patients had ad lib access to analgesics administered via PCA or a nurse".

Group 1 (GSUC) intervention: Quote "In the GSUC arm, a gauze dressing (Kerlix 4.5 inch roll, Covidien, Mansfield MA) moistened with 0.9% normal saline was applied to the wounds, a red rubber catheter (C.R. Bard, Covington, GA) was placed in the center of the dressing, and the dressing was then sealed with an occlusive cover
(Ioban Antimicrobial Incise Drape, 3M, St Paul, MN). Continuous wall suction at 75 to 80 mm Hg was applied and the dressings were changed daily".

Group 2 (VAC) intervention: Quote "In the VAC arm, GranuFoam black sponge (KCI, San Antonio, TX) was applied to the wounds and sealed with an occlusive plastic cover; continuous suction at 75 to 125 mm Hg was initiated and the dressing was changed every 48 hours, as recommended by VAC therapy guidelines. All components of the dressing were obtained from Kinetics Concepts, Inc.
Study date/s: October 2006 to May 2008


OutcomesMeasures:

  1. Rate of change in surface area between groups (expressed as the rate of change %/day)
  2. Rate of change in wound volume between groups (expressed as the rate of change %/day)
  3. Cost/day
  4. Pain measured using a 0 to 10 linear analogue scale and reported as the "sum of pain intensity differences"
  5. Wound complications
  6. Adverse events


Validity of measure/s:

  1. "Wound size was calculated using the Xakellis and Frantz method: wound surface area = length X width X 0.783; wound volume area = area X depth X 0.327".
  2. Pain was self reported and measured "according to the 0 to 10 linear analogue scale immediately before, during, and after removal of the dressing. The sum of pain intensity differences (SPID) was used to facilitate comparison of pain levels between the 2 groups. The SPID score was calculated using the formula: (pain during - pain before) + (pain after - pain during)."


Time points: data collected up to day 7 were included in the analyses


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskEvidence: Quote "The randomization sequence was generated from the Web site http://www.randomization.com".
Comment: blocking not mentioned

Allocation concealment (selection bias)Unclear riskEvidence: Quote "On enrolment, patients were then randomized to either GSUC or VAC therapy in a 1:1 ratio by drawing a previously prepared card".

Blinding of participants and personnel (performance bias)
All outcomes
High riskEvidence for participants: Quote "The 2 methods of SAWT were obviously and visibly different, so it was impossible to blind either the therapists or the patients to the method of treatment".

Evidence for personnel: Quote "The 2 methods of SAWT were obviously and visibly different, so it was impossible to blind either the therapists or the patients to the method of treatment".

Blinding of outcome assessment (detection bias)
All outcomes
High riskEvidence: Quote "A senior therapist who was highly experienced with both VAC and GSUC changed all of the dressings.

We tried to minimize bias by using therapists who were not participating in the study to gather and record data”

Comment: the therapist was not blinded

Incomplete outcome data (attrition bias)
All outcomes
Low riskEvidence: Quote "An intention-to-treat analysis was performed for all of the primary and secondary outcomes. Forty-five patients in the GSUC group and 42 patients in the VAC group were included in the analyses."

Selective reporting (reporting bias)Low riskComment: all the pre-specified clinical outcomes are presented in Tables 3 and 4. Complications and adverse events are reported in the results section. Measures reflect the aims of the intervention and the pre-defined outcomes listed in the published protocol (NCT00724750), which was sighted.

Other biasUnclear riskEvidence: the study began in 2006 but the protocol was Quote "First Received on July 25, 2008" at ClinicalTrials.gov

Comment: potential for study characteristics to have changed before or during the study

Howell 2011

MethodsStudy design: randomised controlled trial
Ethics and informed consent: not reported

Sample size calculation: yes

ITT analysis: all participants completed the study


ParticipantsLocation: NYU Hospital for Joint Disorders, New York, NY, USA
Mean age Group 1: not reported;Mean age Group 2: not reported
Inclusion criteria: patients undergoing unilateral or bilateral primary TKA who were obese (BMI > 30), who met criteria of increased risk for postoperative wound drainage and who were prescribed enoxaparin sodium for deep venous thrombosis (DVT) prophylaxis
Exclusion criteria: patient refusal to participate in the study, revision TKR, prior knee surgery (except arthroscopy), and patients with documented diabetes mellitus were excluded from the study


InterventionsAim/s: to compare the number of days to dry wound between a negative pressure dressings group compared with static pressure dressings group
Intervention/s in both groups: "All patients received three doses of peri-operative intravenous antibiotics and were maintained on subcutaneous DVT prophylaxis for 30 days after surgery".

Group 1 (NPD) intervention: "Subsequent to the closure of the surgical incision, a negative pressure dressing (VAC Therapy, Kinetic Concepts Inc., San Antonio, Texas) was applied under sterile conditions. A medical grade open cell polyurethane ether foam (pore size of 400--600 micrometers) was cut into the shape of a rectangle approximately 5 cm in width and a length sufficient to cover the entire linear wound. The knee was held in 151 of flexion, and the foam was secured over the incision by the application of a specialized adhesive drape, provided in the VAC Therapy system. An evacuation tube with side ports was embedded within the reticulated foam, allowing negative pressure to be applied equally over the entire wound bed. The foam-evacuation tube complex attached to a programmable vacuum pump applied a 125 mmHg continuous vacuum pressure to the wound.

The VAC Therapy dressing remained in place for a 48-hour period, after which time clean, dry gauze dressings were applied and changed on daily basis until the wound was dry".

Group 2 (SPD) intervention: "Patients in the control arm had their surgical wound covered in the operating room with a sterile, dry gauze dressing that was held in place with a perforated, stretchable cloth tape. This initial dressing remained in place for 48 hours after which time clean, dry gauze dressings were applied and changed on a daily basis until the wound was dry."
Study date/s: not stated


OutcomesMeasures:

  1. Days to dry wound
  2. Deep wound infection
  3. Blister formation


Time points: patients followed for 12 months post surgery


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskComment: not described

Allocation concealment (selection bias)Low riskEvidence: Quote “randomized with blinded envelopes to either the treatment with negative pressure wound therapy group or a control group using sterile gauze"

Blinding of participants and personnel (performance bias)
All outcomes
High riskEvidence: not described

Comment: difference in appearance of dressings made blinding impossible

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskEvidence: not described

Incomplete outcome data (attrition bias)
All outcomes
Low riskEvidence: 51 patients were randomised and 51 completed the study

Selective reporting (reporting bias)Low riskComment: the pre-specified clinical outcomes are presented in Table 1. A post hoc analysis of blister occurrence is shown in Table 2. Infection rates are reported in the results section. No published protocol was found.

Other biasUnclear riskNo baseline data are presented. In addition, groups contained unequal numbers, which may indicate undisclosed losses in one group

The study was supported by KCI, the manufacturer of the negative pressure device

Llanos 2006

MethodsStudy design: randomised, double-blind controlled trial
Ethics and informed consent: ethics approved and consent obtained

Sample size calculation: yes

ITT analysis: yes


ParticipantsLocation: Burn & Plastic Surgery Unit, Santiago, Chile
Mean age Group 1: 34 (20 to 52);Mean age Group 2: 34.5 (19 to 58)
Inclusion criteria: Quote "all patients who were admitted at the hospital with acute traumatic injuries and skin loss, which hindered primary closure, underwent a surgical cleaning of their wound, and had a quantitative biopsy culture performed on their wound. Those patients whose biopsy culture had a bacterial count lower than 100,000 colony forming units per gram of tissue and who had given informed consent to enter the study were recruited".
Exclusion criteria: those who Quote "had burns that covered 20%, or more, of their total body surface; were polytraumatized; had surgical contraindications because of medical, anesthetic (serious associated pathology), or surgical cause (hypoalbuminemia or systemic infection); or were enlisted in other clinical trials".


InterventionsAim/s:

Primary: to determine if the negative pressure closure diminishes the area loss of the skin grafts

Secondary: to determine if 1) the negative pressure closure shortens hospital stay, or if secondary wound coverage procedures are needed; and 2) to determine if there is a relation between the area loss of the skin graft and the total grafted surface.
Intervention/s in both groups: Quote"The graft was covered with a single layer of paraffin gauze dressing (Jelonet, Smith & Nephew, England); then, 3 sheets of polyurethane (high-density foam, Nuris Luisa, Santiago, Chile) with a fenestrated silicone drainage tube between the layers was placed over the gauze and covered with a transparent adhesive dressing (Op site, Smith & Nephew) providing the vacuum seal. We used a double layer under the tube to prevent pressure ulcers at the bed of the suction tube.

Group 1 (NPC) intervention: Quote "The suction tube was connected to the central aspiration system at a pressure of −80 mm Hg, and the integrity of the vacuum seal was tested and reinforced with cotton dressing and an elastic gauze bandage if necessary".

Group 2 (Control) intervention: the control group Quote "only differed from the active group in that it lacked a connection to the central aspiration system (i.e., negative pressure vacuum)".
Study date/s: May 2003 to October 2004


OutcomesMeasures:

  1. Area loss of skin graft in cm2
  2. Need for re-grafting
  3. Length of hospital stay
  4. Complications


Validity of measure/s: Quote "Digital photographs, without flash, were taken from a distance of 40 cm from the wound to evaluate the areas of loss at the moment of uncovering the graft. Afterward, these images were analyzed with the Autocad (Autodesk, Inc, 2001, Fremont, CA) software, measuring the loss in cm2".

Time points: fourth postoperative day


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskEvidence: Quote "Treatment assignment was performed using computer-generated random numbers in permuted blocks of 6".

Allocation concealment (selection bias)High riskEvidence: Quote "The treatment allocation of each patient was performed by the nurse of the operating room who knew the corresponding assignment".

Comment: follow-up correspondence with the author indicated Quote "the theatre nurse had a list of randomization with computer generated random numbers". So allocation was not concealed.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskEvidence for participants: not described

Comment: dressings were identical. The only difference was that dressing in the NPC group were connected to an 'active' suction device. Potential for participant to notice this.

Evidence for personnel: Quote "The corresponding treatment was notified to the surgeon only once the skin graft had been performed so that the surgeon did not modify his technique according to the assignation of treatment".

Comment: once surgery was completed, other personnel would have been aware of group assignment (active suction or not). Whether this would have affected outcomes is unclear.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskEvidence: Quote "The person in charge of measuring the areas in the photographic register was masked to which intervention the patient had received. That way, at the moment of evaluating the photograph, this person did not know whether or not the patient had undergone NPC. In addition, the data analyst was masked to the groups of intervention at the moment of analyzing the results".

Incomplete outcome data (attrition bias)
All outcomes
Low riskEvidence: Quote "All the patients were analyzed in the group to which they were assigned, adhering to the intention-to-treat principle". "In our study, there were no drop-outs, drop-ins, or noncompliant patients. Furthermore, no patients refused to take part in the study".

Selective reporting (reporting bias)Low riskComment: all the pre-specified clinical outcomes are presented in Table 2 and in Figures 4 and 5. Adverse events are reported in the Results section. Measures reflect the aims of the intervention and the pre-defined outcomes. A published protocol was not available.

Other biasLow riskEvidence: Quote "The authors have no conflicts of interest with any of the manufacturing companies of the products used in the present study".

Comment: no other potential biases were identified

Pachowsky 2011

MethodsStudy design: randomised controlled trial
Ethics and informed consent: ethics approved and consent obtained

Sample size calculation: no

ITT analysis: yes


ParticipantsLocation: University hospital in Erlangen, Germany
Mean age Group 1: 70.0 (SD 11.01);Mean age Group 2: 66.2 (SD 17.83)
Inclusion criteria: Quote "consecutive patients who were scheduled for a total hip arthroplasty (THA) for osteoarthritis of the hip were randomised".
Exclusion criteria: Not stated


InterventionsAim/s:

Primary : to evaluate the effect of NPWT on postoperative seroma

Secondary :
Intervention/s in both groups: Quote"The surgical intervention was identical for both groups. All patients received two Redon drains, one in the deep area of the wound close to the prostheses and one above the closed fascia. The postoperative physiotherapy and mobilisation was also identical for both groups. Both groups received perioperative prophylaxis with antibiotics either Augmentin (amoxicillin trihydrate with potassium clavulanate) or ciprofloxacin".

Group 1 (NPWT) intervention: Quote "The NPWT group was treated with a PREVENA™ system (KCI, San Antonio, USA). The PREVENA system was left on the wound for five days including the day of surgery.".

Group 2 (Control) intervention: the control group received Quote "the standard wound dressing of our department, consisting of a dry wound coverage".
Study date/s: Not stated


OutcomesMeasures:

  1. Incidence of seroma (by ultrasound)
  2. Amount of wound drainage in the Redondrain canisters
  3. Duration of prophylactic antibiotics
  4. Secretion from the wound


Validity of measure/s: Quote "All patients underwent an ultrasound (Zonare, Z.one Ultra SP 4.2, Erlangen, ZONARE Medical Systems, Inc., Mountain View, USA) of the wound".

Time points: fifth and 10th post-operative days


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot stated

Allocation concealment (selection bias)Unclear riskNot stated

Blinding of participants and personnel (performance bias)
All outcomes
High riskEvidence for participants: not described

Comment: difference in appearance of dressings made blinding impossible

Evidence for personnel: not described

Comment: difference in appearance of dressings made blinding impossible

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskDressings were left in place for five days. The ultrasound was performed on day five. It is unclear if the person performing the ultrasound was aware of the allocated group.

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll enrolled patients were accounted for in the analyses

Selective reporting (reporting bias)Unclear riskResults for outcomes identified in the methods section were reported. The protocol was not sighted.

Other biasUnclear riskEvidence: Quote "Matthias H. Brem gave scientific presentations for KCI. The PREVENATM wound treatment system was provided by KCI free of charge."

One patient in the NPWT group removed the Redon drain by himself on the first postoperative day

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Hu 2009Acute, sub-acute and chronic wounds were included. Acute wounds were defined as those that had been 'open' for less than 1 week.

Johannesson 2008The intervention dressing was not a continuous negative pressure device.

Kim 2007The study was not a randomised controlled trial.

Moues 2004No acute wounds were included.

Moues 2007No acute wounds were included.

 
Characteristics of studies awaiting assessment [ordered by study ID]
Braakenburg 2006

MethodsRandomised controlled trial

Participants65 patients with chronic and acute wounds

InterventionsVacuum-assisted closure versus static pressure dressing

OutcomesPain, antibiotic use, wound and granulation surface measurement

NotesResults of chronic and acute wounds presented together. Details of acute wounds alone requested from investigator.

Moisidis 2004

MethodsRandomised controlled trial

Participants22 patients with chronic, sub-acute and acute wounds (10 with acute wounds)

InterventionsVacuum-assisted closure versus static pressure dressing

OutcomesEpithelialisation, proportion of graft take

NotesResults of chronic and acute wounds presented together. Details of acute wounds alone requested from investigator.

 
Characteristics of ongoing studies [ordered by study ID]
Chan 2011

Trial name or titleA prospective randomised controlled trial of negative pressure suction dressing and early mobilisation in the management of lower leg skin grafts

MethodsRandomised controlled trial

ParticipantsPatients with lower leg wounds requiring split skin grafting for primary closure, e.g. post planned skin lesion removal or trauma

InterventionsNegative pressure dressing versus static pressure dressing

OutcomesPrimary: graft success at day 5 to 7 when dressing is removed. Secondary: graft success at 6-week follow-up.

Starting dateEarly 2011

Contact informationMark.Wade@waitematadhb.govt.nz; richard.martin@waitematadhb.govt.nz

Notes

Graves 2011

Trial name or titleIncisional wound vac in obese patients

MethodsRandomised controlled trial

ParticipantsObese patients after standard closure of trauma-related, operative orthopaedic incisions

InterventionsNegative pressure dressing versus static pressure dressing

OutcomesDrainage from incisional wound

Starting dateEstimated December 2010

Contact informationMatthew Graves (mgraves@umc.edu); Lori Smith (lsmith6@umc.edu)

NotesInvestigator contacted. Awaiting response.

 
Comparison 1. Negative pressure versus standard dressing

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

 1 Adverse events2110Risk Ratio (M-H, Random, 95% CI)0.61 [0.33, 1.13]

 2 Fracture blisters1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 3 Seroma1Odds Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Comparison 2. Negative pressure GSUC versus negative pressure VAC

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

 1 Adverse events187Risk Ratio (M-H, Fixed, 95% CI)0.13 [0.01, 2.51]