Tissue Quality of Integra vs. BTM Treated Burns (NCT06760611) | Clinical Trial Compass
WithdrawnNot Applicable
Tissue Quality of Integra vs. BTM Treated Burns
Stopped: change in company prioritizations
0Started 2025-03-01
Plain-language summary
An observational analysis of Integra-treated burns and Novosorb Biodegradable Temporizing Matrix (BTM)-treated burns will be undertaken 12-36 months post final skin graft application by retrospectively analyzing the patient's electronic medical record, and prospectively using a non-invasive measures of tissue quality and patient-reported outcomes. Patients will be offered the option to consent for a tissue biopsy for pathological evaluation.
Who can participate
Age range
21 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
. Patient has reviewed the IRB-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the IRB-approved consent form.
. Patient had a deep dermal or full-thickness burn that required skin grafting that was first treated with Integra\* or BTM, and at least 70% 'take' followed by an autograft
. Patient had final skin graft between 12-36 months prior enrollment in the study.
. Burn must have been ≥10% total body surface area (TBSA) and ≤70% TBSA.
. Patient is ≥ 21 years of age at the time of treatment.
Exclusion criteria
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.
What they're measuring
1
Time from Integra or BTM treated burns to autograft procedure
Timeframe: 12-36 months post final skin graft application
2
Vancouver Scar Scale assessment of tissue quality
Timeframe: 12-36 months post final skin graft application