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

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04829331
• Other study ID #: 21-RES-003
• Status: Terminated
• Phase: N/A
• Start date: April 9, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: March 2023
• Source: Acera Surgical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wound Heal

Intervention

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

Locations

Country	Name	City	State
United States	Nebraska Methodist Hospital	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Acera Surgical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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