NCT03340025

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

Completed NA Results posted Last updated 30 July 2021

What this trial tests

NA trial testing PICO Single Use Negative Pressure Wound Therapy System in Surgical Wound in 20 participants. Completed in 15 June 2021.

Timeline

15 June 2018

Primary endpoint
13 April 2020

15 June 2021

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	15 June 2018
Primary completion	13 April 2020
Estimated completion	15 June 2021
Sites	1 location across United States

Drugs / interventions tested

• PICO Single Use Negative Pressure Wound Therapy System
• xeroform gauze

Conditions studied

• Surgical Wound — all drugs for Surgical Wound →

Sponsor

University of Alabama at Birmingham

Who can join

18 and older, any sex, with Surgical Wound. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression of Wound Healing Primary · 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.

Group	Value	95% CI
Negative Pressure Wound Therapy	69.9	50 – 90
Conventional Dressing	75.6	55 – 95

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.