N/A
N=20
Single-Use Negative Pressure Wound Therapy for Free Flap Donor Sites
Surgical Wound
Bottom Line
View on ClinicalTrials.gov: NCT03340025 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Progression of Wound Healing — 69.9; 75.6 percentage of skin graft take
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PICO Single Use Negative Pressure Wound Therapy System (Device); xeroform gauze (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression of Wound Healing |
69.9; 75.6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03340025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.