Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site

Study Overview
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Brief Summary
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Adult patients undergoing a radial forearm free flap or ulnar forearm free flap will be randomized to the use of the Restrata graft in combination with split-thickness skin graft for reconstruction. Photos will document whether the Restata graft aids in the healing.

Official Title
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Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Device: Restrata Graft
* Procedure: Standard of Care Skin Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap. Photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient. Exclusion Criteria: Active systemic immunosuppression (active use of high-dose steroids (≥40mg prednisone daily or equivalent) or other immunosuppressive medications OR medical conditions causing immunosuppression, i.e. human immunodeficiency virus etc). Diabetes mellitus with most recent Hemoglobin A1c ≥10.0 within 30 days prior to surgery. Morbid obesity (BMI >40). Inability to maintain wrist immobilization for full planned period. Severe malnutrition (prealbumin levels <10 mg per dL within 30 days prior to surgery OR BMI <15 (very severely underweight). Other conditions felt to significantly impair wound healing per surgeon discretion

Ages Eligible for Study
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Minimum Age: 19 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A - Standard of Care<br> | Procedure: Standard of Care Skin Graft<br>* Standard of Care Skin Graft<br>|
| Experimental: B - Restrata Graft<br> | Device: Restrata Graft<br>* Restrata will be meshed in a 1:2 fashion to allow for egress of serous fluid and minimize risk of fluid collection. Restrata will be applied to the entire wound bed not amenable to primary closure and will be underlaid beneath the surrounding skin edges. A split-thickness skin graft is harvested from patient's thigh at 15:1000 inches and placed on top of the Restrata to cover the entire wound bed. The graft is sutured in place using suture choice of surgeon's preference.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tendon exposure | Tendon exposure at four weeks post-operatively (Yes/No). | 4 weeks post-operation | 
| Percentage of surface area | Percentage of surface area of split-thickness skin graft incorporation at four weeks postoperatively. | 4 weeks post operation |