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

Stopped early · Not applicable

Conditions studied: Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT02980601

Run by

Wake Forest University Health Sciences

People needed

10

Starts

2015-11-01

Expected to finish

2018-08-06

Last updated by the study team

2019-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All subjects who receive a radial forearm free flaps in the included time period, including subjects with head and neck cancer, traumatic defects, chronic wounds, or any other problems that require a radical forearm free flap for reconstruction.
• Have had a distal, anterograde fasciocutaneous flap
• Age ≥ 18 years
• Ability to understand and the willingness to sign an IRB-approved informed consent document.
• Smokers and tobacco users will be included in this study

You may not qualify if…

• Subjects who have had an osteocutaneous or musculocutaneous flap.
• Subjects who have a radial forearm flap with a proximal skin flap or subjects that receive a "reverse" radial forearm flap
• Pregnant women will be excluded due to the lack of clinical studies evaluating INTEGRA template in pregnant women.

Where it is running

• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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