TerminatedNot Applicable

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

Stopped: Lack of clinical research staff

United States5 participantsStarted 2021-04-09

Plain-language summary

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

Who can participate

Age range19 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Tendon Exposure

Timeframe: 4 weeks post-operatively

Surface Area of Split-thickness Skin Graft Incorporation

Timeframe: 4 weeks post-operatively

Trial details

NCT IDNCT04829331

SponsorAcera Surgical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-01

Results submitted2023-02-06

View on ClinicalTrials.gov More Wound Heal trials