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

Surgical Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03340025
• Other study ID #: IRB-300000596
• Status: Completed
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: June 15, 2021

Study information

• Verified date: July 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 15, 2021
• Est. primary completion date: April 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Surgical Wound
• Wounds and Injuries

Intervention

Device:
• PICO Single Use Negative Pressure Wound Therapy System
Class II negative pressure wound therapy powered suction pump
• xeroform gauze
traditional surgical dressing of xeroform gauze and padding

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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