StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects… (NCT03005106) | Clinical Trial Compass
CompletedPhase 3
StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements
United States71 participantsStarted 2017-05-30
Plain-language summary
About 70 participants will be enrolled. They will have complex skin defects because of burns caused by heat.
The burns will:
* be on 3-49% of the participant's total body surface area (TBSA)
* require surgery for skin replacement
* include intact dermal elements
The burns are called deep, partial-thickness thermal burns because the skin was damaged by heat but still has some dermis that was not damaged.
The dermis is the layer of skin under the outer layer (epidermis). It is the thickest layer of the skin that provides strength and flexibility to the skin.
All patients will receive both treatments, but on different areas of their burns. Their wounds will not be compared to other patients. One treatment area on their own body will be compared to the other one.
This will help to find out if StrataGraft is safe and effective for deep partial thickness burns. It will also see if StrataGraft might help healing enough to use it instead of the patient's own healthy skin to repair the damage.
Who can participate
Age range
18 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 years
. Written informed consent
. Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
. Clinical expectation that the study donor site will heal without grafting
. Complex skin defects of 3-49% TBSA
. Thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated
. Total of both study treatment areas can be up to 2000 cm2
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
Percent Area of Treatment Sites Requiring Autografting by Month 3
Timeframe: 3 Months
2
Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3)