Status:
TERMINATED
Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site
Lead Sponsor:
Nebraska Methodist Health System
Collaborating Sponsors:
Acera Surgical, Inc.
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
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. P...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04880603
Start Date
April 5 2021
End Date
April 25 2022
Last Update
May 13 2022
Active Locations (1)
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1
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114