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

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

Study Overview

• Status: Terminated
• Conditions: Wound Heal
• Intervention / Treatment: Device: Restrata

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Restrata with a split-thickness skin graft	Device: Restrata; Restrata is a sterile, single use device intended for use in local management of wounds
No Intervention: Split-thickness skin graft alone

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Acera Surgical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 21-RES-003

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.: No