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

Acera Surgical

Status: Terminated

Conditions: Wound Heal

Treatments: Device: Restrata

Study type: Interventional

Funder types: Industry

Identifiers

NCT04829331

21-RES-003

Details and patient eligibility

About

Understand association between use of Restrata (Acera Surgical Inc., St. Louis, MO) in forearm flap reconstruction with donor site healing and function

Enrollment: 5 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5 participants in 2 patient groups

Restrata with a split-thickness skin graft

Experimental group

Treatment:

Device: Restrata

Split-thickness skin graft alone

No Intervention group