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

Study Overview
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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.

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.

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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Device: Integra plus STSG
* Procedure: STSG


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integra and a Split Thickness Skin Graft (STSG)<br>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. | Device: Integra plus STSG<br>* 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<br>Procedure: STSG<br>* 0.012mm STSG<br>|
| Active Comparator: Split Thickness Skin Graft (STSG)<br>reconstruction as dictated by the protocol. They will either receive 1) a 0 | Procedure: STSG<br>* 0.012mm STSG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Skin Graft Necrosis. | Number of participants with skin graft necrosis. | 1 year | 
| Vancouver Scar Scale | The Vancouver Scar Scale will measure donor site aesethetic quality and it encompasses 4 separate outcomes to be objectively assessed. Each has been separately reported in the literature for each group in different papers as previously mentioned. We will compare the final score as well as scores within each outcome.On a scale of 1-13; with higher score denoting worse outcome. | 1 Year | 
| Vancouver Scar Scale - Pigmentation | Pigmentation will be measured on the Vancouver Scar Scale. On a scale of 0-2; higher score denoting worse outcome. | 1 year | 
| Vancouver Scar Scale - Vascularity | Vascularity will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome. | 1 year | 
| Vancouver Scar Scale - Pliability | Pliability will be measured on the Vancouver Scar Scale. On a scale of 1-5; higher score denoting worse outcome. | 1 year | 
| Vancouver Scar Scale - Height | Height will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome. | 1 year | 
| Hand Strength -Lateral Pinch | Functional outcomes will be measured by using strength dynamometers. | Pre-op | 
| Hand Strength -Lateral Pinch | Functional outcomes will be measured by using strength dynamometers. | 3 month | 
| Hand Strength -Lateral Pinch | Functional outcomes will be measured by using strength dynamometers. | 6 months | 
| Hand Strength -Lateral Pinch | Functional outcomes will be measured by using strength dynamometers. | 1 year | 
| Hand Strength - Grip | Functional outcomes will be measured by using strength dynamometers. | pre-op | 
| Hand Strength - Grip | Functional outcomes will be measured by using strength dynamometers. | 3 month | 
| Hand Strength - Grip | Functional outcomes will be measured by using strength dynamometers. | 6 month | 
| Hand Strength - Grip | Functional outcomes will be measured by using strength dynamometers. | 1 year | 
| Hand Strength- Pincer | Functional outcomes will be measured by using strength dynamometers | pre-op | 
| Hand Strength- Pincer | Functional outcomes will be measured by using strength dynamometers | 3 month | 
| Hand Strength- Pincer | Functional outcomes will be measured by using strength dynamometers | 6 month | 
| Hand Strength- Pincer | Functional outcomes will be measured by using strength dynamometers | 1 year | 
| Wrist Range of Motion- Flexion | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | pre-op | 
| Wrist Range of Motion- Flexion | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | 3 month | 
| Wrist Range of Motion- Flexion | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | 6 month | 
| Wrist Range of Motion- Flexion | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | 1 year | 
| Wrist Range of Motion- Extension | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | pre-op | 
| Wrist Range of Motion- Extension | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | 3 month | 
| Wrist Range of Motion- Extension | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | 6 month | 
| Wrist Range of Motion- Extension | Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension | 1 year | 
| Number of Participant With Tendon Exposure | Tendon exposure identified clinically. | 6 month | 
| Rate of Tendon Exposure | Tendon exposure identified clinically. | 1 year | 
| Patient Scar Assessment- Paresthesia | Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes | 3 month | 
| Patient Scar Assessment- Paresthesia | Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes | 6 month | 
| Patient Scar Assessment- Paresthesia | Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes | 1 year | 
| The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire) | Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure | pre-op | 
| The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire) | Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure | 3 month | 
| The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire) | Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure | 6 month | 
| The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire) | Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure | 1 year | 
| Percent of Wound Contracture | Planimetry Software will be used to measure and determine percentage of wound contracture | 3 month | 
| Percent of Wound Contracture | Planimetry Software will be used to measure and determine percentage of wound contracture | 6 month | 
| Percent of Wound Contracture | Planimetry Software will be used to measure and determine percentage of wound contracture | 1 year | 
| Skin Pliability | Skin pliability will be measuredusing a Cutometer MPA 580. We plan to measure Pliability (Ua), Elasticity (Ue), Retraction (Ur). Viscoelasticity (Uv), and Extension (Uf). | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic Defect, Chronic Wounds