StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns (NCT01437852) | Clinical Trial Compass
CompletedPhase 1
StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns
United States30 participantsStarted 2011-09
Plain-language summary
The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the healing of the deep partial-thickness component of complex skin defects. The proposed study population will include patients with 3-49% Total Body Surface Area (TBSA) complex skin defects including a deep partial-thickness component resulting from thermal injury. The study has been designed to focus on the evaluation of safety and tolerability of prolonged exposure to increasing amounts of a single application of StrataGraft skin tissue, while also assessing the potential for StrataGraft tissue to promote healing of the deep partial-thickness component of these complex skin defects as an alternative to donor site harvesting and autografting. Targeted enrollment for this study is up to 30 patients with complex skin defects due to thermal burns which require surgical excision and autografting. Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving StrataGraft skin tissue that has been stored refrigerated prior to clinical use. A third cohort will receive StrataGraft skin tissue which has been stored cryopreserved and thawed in the operating room just prior to grafting.
Who can participate
Age range
18 Years – 65 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:
* Men and women aged 18-65 years, inclusive
* Written informed consent
* Sufficient healthy skin identified and designated as a donor site in the event that the StrataGraft treatment site requires autografting
* Complex skin defects of 3-49% TBSA requiring excision and autografting
* Total burn may consist of more than one wound area
* Deep partial-thickness thermal burn(s) with total area of 88 to 880 cm2 requiring excision and autografting
* First excision and grafting of treatment sites
Exclusion Criteria:
* Pregnant women and prisoners
* Patients receiving systemic immunosuppressive therapy
* Patients with a known history of malignancy
* Preadmission insulin-dependent diabetic patients
* Patients with concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
* Expected survival of less than three months
* Participation in the treatment group of an interventional study within preceding 90 days prior to enrollment
* Full-thickness burns will be excluded as treatment sites
* Chronic wounds will be excluded as treatment sites
* The face, head, neck, hands, feet, buttocks, and areas over joints will be excluded as treatment sites
* Treatment sites adjacent to unexcised eschar
* Clinical suspicion of burn wound infection at the anticipated treatment sites
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
Number of Participants With Wound Closure of the Treatment Sites at Three Months
Timeframe: 3 months
2
Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28