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

Nebraska Methodist Health System

Status and phase

Terminated

Phase 2

Conditions

Head and Neck Cancer

Treatments

Procedure: Standard of Care Skin Graft

Device: Restrata Graft

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04880603

Restrata

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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