Head and Neck Cancer Clinical Trial
Official title:
Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site
Verified date | May 2022 |
Source | Nebraska Methodist Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 5 |
Est. completion date | April 25, 2022 |
Est. primary completion date | April 25, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Nebraska Methodist Hospital | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
Nebraska Methodist Health System | Acera Surgical, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tendon exposure | Tendon exposure at four weeks post-operatively (Yes/No). | 4 weeks post-operation | |
Primary | Percentage of surface area | Percentage of surface area of split-thickness skin graft incorporation at four weeks postoperatively. | 4 weeks post operation |
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