Single-Use Negative Pressure Wound Therapy for Free Flap Donor Sites

Study Overview
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Brief Summary
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Various management options for free flap donor sites that require split thickness skin grafting exist. None has proven superior from both a patient care and a cost standpoint. Major complications occurring at these surgical sites include wound breakdown, tendon exposure, and loss of function. We seek to investigate the use of the PICO single-use negative pressure wound therapy device in these surgical sites and determine if it can yield superior results to simpler methods.

Detailed Description
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Many studies have addressed the use of negative pressure wound therapy (NPWT) in free flap donor sites with mixed results. It is well established that NPWT is safe and causes no harm, and no delay in healing. A previous study performed at UAB showed that NPWT in complex Head & Neck Surgery reconstruction is safe, including free flap donor sites. There have been studies that state the rate of tendon exposure is lower with NPWT in free flap donor sites, and studies that conclude there is no difference in complication rates. Current clinical practice is varied, often within a single institution. While no studies of NPWT in free flap donor sites have noted inferior results with its use, a primary reason cited for not using it is cost. Traditional NPWT using canister-based vacuum devices adds significant cost. The PICO single-use NPWT device (Smith & Nephew) is a relatively inexpensive, low-profile dressing that does not require attachment to an external canister. It is battery-powered and disposable. Empiric use on our patients undergoing split-thickness skin-grafting to free flap donor sites shows good results with minimal intra-operative effort compared to traditional bandaging. We would like to prospectively investigate the use of this low-cost NPWT device and compare it directly to the traditional post-op dressing method.

Official Title
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Single-Use Negative Pressure Wound Therapy for Free Flap Donor Sites

Conditions
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Surgical Wound

Intervention / Treatment
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* Device: PICO Single Use Negative Pressure Wound Therapy System
* Device: xeroform gauze


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years of age participants are able to consent for themselves undergoing reconstructive surgery requiring split-thickness skin graft coverage of a free flap donor site (i.e., radial forearm free flap or fibula free flap) Exclusion Criteria: < 18 years of age participants are unable to consent for themselves undergoing reconstructive surgery that does not require split-thickness skin graft coverage of a free flap donor site

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: negative pressure wound therapy<br>PICO Single Use Negative Pressure Wound Therapy System | Device: PICO Single Use Negative Pressure Wound Therapy System<br>* Class II negative pressure wound therapy powered suction pump<br>|
| Placebo Comparator: conventional dressing<br>traditional surgical wound dressing of xeroform gauze and padding | Device: xeroform gauze<br>* traditional surgical dressing of xeroform gauze and padding<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of Wound Healing | Comparison of photographs of all participants' wounds taken at post-operative Day 5, post-operative Day 14-21, and post-operative Day 30. Percentage skin graft take will be evaluated on Day 30 by blinded, independent raters. A 10x10 grid was digitally overlain on each image. The de-identified images were randomized and given to two independent raters. The raters used three criteria to assess each graft. Overall graft appearance was graded on a 1-5 scale, percent of graft take was estimated, and the presence of exposed tendon was noted for each timepoint. | Baseline through 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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negative pressure wound therapy, split thickness skin graft