StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects (NCT05517902) | Clinical Trial Compass
CompletedPhase 3
StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects
United States1 participantsStarted 2023-04-28
Plain-language summary
Autografting is a surgical procedure to transplant healthy skin (donor skin) from another part of the participant's own body (donor site) to the burned part. Autografting is the usual treatment for DPT burns.
It works to close the wound, but can cause other problems:
* Donor sites are painful, can become infected or scarred, or can even become full thickness (FT) wounds themselves
* Treatment problems can require more grafting
* Additional surgery increases the risk of medical problems caused by the treatment
Stratatech is trying to find a safe and effective alternative to autografting to promote the healing of severe burns. The purpose of this study was to evaluate whether StrataGraft treatment eliminates or reduces the need for autografting and promotes wound closure in a pediatric population with thermal burns that contain intact dermal elements and for which autografting is clinically indicated (DPT burns).
Participants were enrolled into one of two age-based cohorts: 2 to \< 12 years and 12 to ≤ 17 years to receive a single application of StrataGraft, in up to 3 non-contiguous DPT burn areas located on the same extremity or plane of the torso.
Who can participate
Age range
2 Years – 17 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:
* Written informed consent provided by the parent(s) or legal guardian(s) and assent from the child when appropriate
* Have enough healthy skin to reserve as donor site(s), in case autografting becomes necessary
* Thermal burns of no more than a total of 30% TBSA
* Study treatment sites that are DPT in depth and which are clinically indicated for excision and autografting, and located on the torso or extremities
* Study treatment area(s) totaling 0.5% to 10% TBSA and may be composed of up to 3 non-contiguous areas located on the same extremity or plane of the torso
* Sufficient healthy skin available and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
Exclusion Criteria:
* Is pregnant or breastfeeding
* Receiving treatment to suppress the immune system and/or systemic corticosteroids (inhaled corticosteroids are permitted)
* A known history of malignancy
* Pre-admission insulin-dependent diabetes
* Concurrent trauma, conditions, and/or personal situations that, in the opinion of the investigator, may compromise the participant's safety or the study objectives
* A burn injury that occurred ≥ 14 days prior to planned StrataGraft application Is expected to survive less than 12 months
* Is participating in another interventional trial, or did within 90 days before enrollment
* A proposed study treatment site that has been previously excised or autografted; located adjacent to an undebrided/unexcised burn area;…
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
Percentage of Participants Who Achieved Confirmed Complete Closure of StrataGraft Treatment Sites Without Autograft Within 12 Weeks of StrataGraft Application
Timeframe: Up to Week 12
2
Number of Participants With Treatment-emergent Adverse Events (TEAEs)