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

Not Applicable

Terminated

• Conditions: Wound Heal
• Interventions: Device: Restrata

• Registration Number: NCT04829331
• Lead Sponsor: Acera Surgical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-02
• Study Start: 2021-04-09
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Results First Submitted: 2023-02-06
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Results First Posted: 2023-04-18
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restrata with a split-thickness skin graft	Restrata	-

Primary Outcome Measures

Name	Time	Method
Tendon Exposure	4 weeks post-operatively	Percentage of participants with tendon exposure
Surface Area of Split-thickness Skin Graft Incorporation	4 weeks post-operatively	Percentage of surface area of split-thickness skin graft incorporation

Trial Locations

Locations (1)

Nebraska Methodist Hospital; 🇺🇸 Omaha, Nebraska, United States