Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor Site (NCT04829331) | Clinical Trial Compass
TerminatedNot Applicable
Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor Site
Stopped: Lack of clinical research staff
United States5 participantsStarted 2021-04-09
Plain-language summary
Understand association between use of Restrata (Acera Surgical Inc., St. Louis, MO) in forearm flap reconstruction with donor site healing and function
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — can you tell me why it was stopped early, and what that means for what we actually know about whether Restrata works on forearm donor sites?
2Since the trial never finished, is there enough published data from it to understand the safety and effectiveness of using Restrata with a split-thickness skin graft on my forearm, or are we still largely in the unknown?
3One of the things this study was tracking was tendon exposure at the donor site — how serious a complication is that, and how would my own forearm wound be managed to reduce that risk if I'm not in a trial?
4Given that this study was terminated, are there other active or completed trials, or standard-of-care options, that you'd recommend instead for reconstructing a forearm donor site?
5How does the termination of this trial affect your confidence in recommending Restrata as part of my treatment plan, compared to more established wound reconstruction approaches?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tendon Exposure
Timeframe: 4 weeks post-operatively
2
Surface Area of Split-thickness Skin Graft Incorporation