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

NCT03340025 | Completed Results FDA Device

• 1 other identifier: IRB-300000596
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Wound

Keywords

negative pressure wound therapy; split thickness skin graft

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

negative pressure wound therapy

EXPERIMENTAL

PICO Single Use Negative Pressure Wound Therapy System

Device: PICO Single Use Negative Pressure Wound Therapy System

conventional dressing

PLACEBO COMPARATOR

traditional surgical wound dressing of xeroform gauze and padding

Device: xeroform gauze

Interventions

PICO Single Use Negative Pressure Wound Therapy System DEVICE

Class II negative pressure wound therapy powered suction pump

negative pressure wound therapy

xeroform gauze DEVICE

traditional surgical dressing of xeroform gauze and padding

conventional dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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)

You may not qualify if:

• \< 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Limitations and Caveats

The patient population is small. Our statistics indicate that assuming an 80% graft take, the number of patients needed for an appropriately powered study (80%) would be 44 patients in each group, while our study recruited only 9 and 11 patients to each group. This study is limited by missing data. Our study also takes place at a single center and, therefore, surgeon technique must be taken into account as this may have affected the outcomes of our data.

Results Point of Contact

• Title: Benjamin Greene, MD
• Organization: University of Alabama at Birmingham

bjgreene@uabmc.edu

205-801-7855

Study Officials

• Benjamin Greene, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: June 15, 2018
• Primary Completion: April 13, 2020
• Study Completion: June 15, 2021
• Last Updated: July 30, 2021
• Results First Posted: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)