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Head and Neck Cancer

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

Sponsored by Nebraska Methodist Health System

About this trial

Last updated 3 years ago

Study ID

Restrata

Status

Terminated

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
19+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial 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.

What are the participation requirements?

Yes

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.

No

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

Locations

Location

Status