Clinical trial NCT02980601: The Use of Integra in Coverage of Radial Forearm Free Flap Donor Site Defect
Official title: The Use of Integra in Coverage of Radial Forearm Free Flap Donor Site Defect
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Traumatic Defect
Chronic Wounds
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Skin Graft Necrosis.
timeFrame: 1 year
measure: Vancouver Scar Scale
timeFrame: 1 Year
measure: Vancouver Scar Scale - Pigmentation
timeFrame: 1 year
measure: Vancouver Scar Scale - Vascularity
timeFrame: 1 year
measure: Vancouver Scar Scale - Pliability
timeFrame: 1 year
measure: Vancouver Scar Scale - Height
timeFrame: 1 year
measure: Hand Strength -Lateral Pinch
timeFrame: Pre-op
measure: Hand Strength -Lateral Pinch
timeFrame: 3 month
measure: Hand Strength -Lateral Pinch
timeFrame: 6 months
measure: Hand Strength -Lateral Pinch
timeFrame: 1 year
measure: Hand Strength - Grip
timeFrame: pre-op
measure: Hand Strength - Grip
timeFrame: 3 month
measure: Hand Strength - Grip
timeFrame: 6 month
measure: Hand Strength - Grip
timeFrame: 1 year
measure: Hand Strength- Pincer
timeFrame: pre-op
measure: Hand Strength- Pincer
timeFrame: 3 month
measure: Hand Strength- Pincer
timeFrame: 6 month
measure: Hand Strength- Pincer
timeFrame: 1 year
measure: Wrist Range of Motion- Flexion
timeFrame: pre-op
measure: Wrist Range of Motion- Flexion
timeFrame: 3 month
measure: Wrist Range of Motion- Flexion
timeFrame: 6 month
measure: Wrist Range of Motion- Flexion
timeFrame: 1 year
measure: Wrist Range of Motion- Extension
timeFrame: pre-op
measure: Wrist Range of Motion- Extension
timeFrame: 3 month
measure: Wrist Range of Motion- Extension
timeFrame: 6 month
measure: Wrist Range of Motion- Extension
timeFrame: 1 year
measure: Number of Participant With Tendon Exposure
timeFrame: 6 month
measure: Rate of Tendon Exposure
timeFrame: 1 year
measure: Patient Scar Assessment- Paresthesia
timeFrame: 3 month
measure: Patient Scar Assessment- Paresthesia
timeFrame: 6 month
measure: Patient Scar Assessment- Paresthesia
timeFrame: 1 year
measure: The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)
timeFrame: pre-op
measure: The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)
timeFrame: 3 month
measure: The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)
timeFrame: 6 month
measure: The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)
timeFrame: 1 year
measure: Percent of Wound Contracture
timeFrame: 3 month
measure: Percent of Wound Contracture
timeFrame: 6 month
measure: Percent of Wound Contracture
timeFrame: 1 year
measure: Skin Pliability
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: Patient Scar Assessment
timeFrame: 3 month
measure: Patient Scar Assessment
timeFrame: 6 month
measure: Patient Scar Assessment
timeFrame: 1 year
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Joseph Molnar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: