Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor Site
Sponsored by Acera Surgical, Inc.
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 3 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
1. All patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap.
2. Photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient.
Exclusion Criteria
1. 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).
2. Diabetes mellitus with most recent Hemoglobin A1c ≥10.0 within 30 days prior to surgery.
3. Morbid obesity (BMI >40).
4. Inability to maintain wrist immobilization for full planned period.
5. Severe malnutrition (prealbumin levels <10 mg per dL within 30 days prior to surgery OR BMI <15 (very severely underweight).
6. Other conditions felt to significantly impair wound healing per surgeon discretion.