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

Nebraska Methodist Health System1 site in 1 country5 target enrollmentApril 5, 2021

ConditionsHead and Neck Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Head and Neck Cancer
Sponsor: Nebraska Methodist Health System
Enrollment: 5
Locations: 1
Primary Endpoint: Tendon exposure
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 5, 2021

End Date

April 25, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nebraska Methodist Health System

Responsible Party

Sponsor

Eligibility Criteria

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