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

Phase 2

Terminated

• Conditions: Head and Neck Cancer
• Interventions: Device: Restrata Graft; Procedure: Standard of Care Skin Graft

• Registration Number: NCT04880603
• Lead Sponsor: Nebraska Methodist Health System

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-05
• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-11
• Primary Completion: 2022-04-25
• Study Completion: 2022-04-25
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B - Restrata Graft	Restrata Graft	-
A - Standard of Care	Standard of Care Skin Graft	-

Primary Outcome Measures

Name	Time	Method
Tendon exposure	4 weeks post-operation	Tendon exposure at four weeks post-operatively (Yes/No).
Percentage of surface area	4 weeks post operation	Percentage of surface area of split-thickness skin graft incorporation at four weeks postoperatively.

Trial Locations

Locations (1)

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