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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2021-06-15

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.

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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.

Conditions

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Surgical Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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negative pressure wound therapy

PICO Single Use Negative Pressure Wound Therapy System

Group Type EXPERIMENTAL

PICO Single Use Negative Pressure Wound Therapy System

Intervention Type DEVICE

Class II negative pressure wound therapy powered suction pump

conventional dressing

traditional surgical wound dressing of xeroform gauze and padding

Group Type PLACEBO_COMPARATOR

xeroform gauze

Intervention Type DEVICE

traditional surgical dressing of xeroform gauze and padding

Interventions

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PICO Single Use Negative Pressure Wound Therapy System

Class II negative pressure wound therapy powered suction pump

Intervention Type DEVICE

xeroform gauze

traditional surgical dressing of xeroform gauze and padding

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No