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

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.

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.