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

NCT04829331 | Terminated Results FDA Device

• 1 other identifier: 21-RES-003
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Restrata with a split-thickness skin graft

EXPERIMENTAL

Device: Restrata

Split-thickness skin graft alone

NO INTERVENTION

Interventions

Restrata DEVICE

Restrata is a sterile, single use device intended for use in local management of wounds

Restrata with a split-thickness skin graft

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acera Surgical, Inc.: lead

Study Sites (1)

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Results Point of Contact

• Title: Matthew MacEwan
• Organization: Acera Surgical

macewan@acera-surgical.com

440-477-1890

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 2, 2021
• Study Start: April 9, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: April 18, 2023
• Results First Posted: April 18, 2023

Record last verified: 2023-03

Locations

US (1)