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

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.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Procedure: Standard of Care Skin Graft; Device: Restrata Graft

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: A - Standard of Care	Procedure: Standard of Care Skin Graft; Standard of Care Skin Graft
EXPERIMENTAL: B - Restrata Graft	Device: Restrata Graft; Restrata will be meshed in a 1:2 fashion to allow for egress of serous fluid and minimize risk of fluid collection. Restrata will be applied to the entire wound bed not amenable to primary closure and will be underlaid beneath the surrounding skin edges. A split-thickness skin graft is harvested from patient's thigh at 15:1000 inches and placed on top of the Restrata to cover the entire wound bed. The graft is sutured in place using suture choice of surgeon's preference.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nebraska Methodist Health System
• Collaborators: Acera Surgical, Inc.
• Investigators: Principal Investigator: Robert Lindau, MD, Nebraska Methodist Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 5, 2021
• Primary Completion (ACTUAL): April 25, 2022
• Study Completion (ACTUAL): April 25, 2022

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (ACTUAL): May 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: Restrata

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes