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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-08-06

Brief Summary

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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.

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Detailed Description

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The radial forearm fasciocutaneous free flap (hereafter referred to as RFFF) was described more than 30 years ago as a fasciocutaneous flap for microsurgical transfer. It was soon after established as a safe and reliable flap for transfer of fascia and cutaneous tissue. Currently, it is used to repair any defect in which a relatively thin island of skin is needed with a fascial strength layer . While the flap itself is very reliable, it leaves a donor site that can be very unsightly and has multiple known complications including loss of pronation, pain, paresthesias, cold intolerance, and skin graft necrosis. The donor site is typically covered with a split thickness skin graft (hereafter referred to as STSG). In an effort to minimize these complications, several groups have described a technique of placing Integra© dermal substitute (hereafter referred to as Integra) underneath the STSG to provide a thicker support and decrease overall morbidity associated with the defect. These studies have shown success in decreasing overall morbidity including increasing range of motion and improving aesthetic quality of the donor site. However, the largest study to date has included only 29 subjects. Furthermore, these studies do not provide a comparative cohort of subjects repaired with a classic STSG to show effectiveness of this technique when compared to a classic repair. Our goal is to perform a prospective study comparing subjects repaired with a classic STSG and those repaired with one step Integra and STSG applied at the same time. These subjects will be evaluated for overall donor site aesthetic quality and functional outcome as described below.

Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Integra and a Split Thickness Skin Graft (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.

Group Type EXPERIMENTAL

Integra plus STSG

Intervention Type DEVICE

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

STSG

Intervention Type PROCEDURE

0.012mm STSG

Split Thickness Skin Graft (STSG)

reconstruction as dictated by the protocol. They will either receive 1) a 0

Group Type ACTIVE_COMPARATOR

STSG

Intervention Type PROCEDURE

0.012mm STSG

Interventions

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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

Intervention Type DEVICE

STSG

0.012mm STSG

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No