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

Primary Purpose

Surgical Wound

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PICO Single Use Negative Pressure Wound Therapy System
xeroform gauze
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound focused on measuring negative pressure wound therapy, split thickness skin graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

negative pressure wound therapy

conventional dressing

Arm Description

PICO Single Use Negative Pressure Wound Therapy System

traditional surgical wound dressing of xeroform gauze and padding

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 8, 2017
Last Updated
July 12, 2021
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03340025
Brief Title
Single-Use Negative Pressure Wound Therapy for Free Flap Donor Sites
Official Title
Single-Use Negative Pressure Wound Therapy for Free Flap Donor Sites
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
April 13, 2020 (Actual)
Study Completion Date
June 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound
Keywords
negative pressure wound therapy, split thickness skin graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
negative pressure wound therapy
Arm Type
Experimental
Arm Description
PICO Single Use Negative Pressure Wound Therapy System
Arm Title
conventional dressing
Arm Type
Placebo Comparator
Arm Description
traditional surgical wound dressing of xeroform gauze and padding
Intervention Type
Device
Intervention Name(s)
PICO Single Use Negative Pressure Wound Therapy System
Intervention Description
Class II negative pressure wound therapy powered suction pump
Intervention Type
Device
Intervention Name(s)
xeroform gauze
Intervention Description
traditional surgical dressing of xeroform gauze and padding
Primary Outcome Measure Information:
Title
Progression of Wound Healing
Description
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.
Time Frame
Baseline through 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Greene, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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