Microscopic Skin Tissue Column Grafting Technique Using the Autologous Regeneration of Tissue System (NCT05324514) | Clinical Trial Compass
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Microscopic Skin Tissue Column Grafting Technique Using the Autologous Regeneration of Tissue System
40 participantsStarted 2022-10-01
Plain-language summary
This study evaluates Microscopic Skin Tissue Column (MSTC) grafting technique using the Autologous Regeneration Tissue (ART) System in the treatment of skin loss. Each participant will have three study treated areas, the three treatments include: 1. traditional grafting, 2. high density MSTC, 3. low density MSTC.
Who can participate
Age range
18 Years – 70 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:
* Age greater than or equal to 18 and age less than or equal to 70.
* Skin loss from surgery, trauma, and/or burns.
* Presence of one uniform contiguous wound ≥150cm2
* Sufficient non-injured healthy skin from which conventional STSG can be harvested to cover study and non-study sites.
* Sufficient non-injured healthy skin from which the study device can be used to harvest MSTC to cover the study sites.
* Study donor site has not been previously harvested.
* Able and likely to follow-up, to have three consecutive appointments and appear for 6 month follow up visit.
* Subject agrees to abstain from enrollment in any other interventional clinical trial while enrolled in this study.
Exclusion Criteria:
* Exposure of tendon, bone devoid of peritenon or periosteum, or other structures deemed non-graftable by the treating physician or study investigator.
* Concomitant skin disease/infection at the recipient or donor sites.
* Use of topical steroid, anti-metabolite, or other pharmacologic therapy on study site.
* Use of systemic steroids in the past month.
* Concurrent conditions that in the opinion of the investigator may compromise subject safety, study objectives or wound healing.
* Current recipient of immunosuppressive therapy.
* Current treatment with medication that inhibit/compromise wound healing.
* Known history of malignancy.
* Pregnancy or lactation
* Prisoner
* History of noncompliance -\>40% total body surface area involvement.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.