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The Use of Integra in Coverage of Radial Forearm Free Flap Donor Site Defect

NCT02980601 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-05-24

Study results available
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Summary

The purpose of this research study is to compare the forearm free flap of patients with a traditional split thickness skin graft and those repaired with Integra (a skin substitute that helps to provide wound closure) and a split thickness skin graft. The study team will be looking at the subject's satisfaction with how the skin graft site looks and how well the skin graft site is functioning.

Conditions

Interventions

DEVICE

Integra plus STSG

A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG

PROCEDURE

STSG

0.012mm STSG

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Joseph Molnar, MD, PhD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-08-18
Completion
2018-08-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02980601 on ClinicalTrials.gov