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

May 9, 2022 updated by: Nebraska Methodist Health System
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nebraska Methodist Health System

Collaborators

Acera Surgical, Inc.

Investigators

  • Principal Investigator: Robert Lindau, MD, Nebraska Methodist Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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