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

Not Applicable

Completed

Interventions: Device: PICO Single Use Negative Pressure Wound Therapy System
Device: xeroform gauze

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
negative pressure wound therapy	PICO Single Use Negative Pressure Wound Therapy System	PICO Single Use Negative Pressure Wound Therapy System
conventional dressing	xeroform gauze	traditional surgical wound dressing of xeroform gauze and padding

Primary Outcome Measures

Name	Time	Method
Progression of Wound Healing	Baseline through 30 days	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.

Secondary Outcome Measures

Name	Time	Method

Locations (1): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States

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