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 range18 Years
SexALL
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Inclusion criteria
✓. Men and women aged ≥ 18 years
âś“. Written informed consent
âś“. Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
âś“. Clinical expectation that the study donor site will heal without grafting
âś“. Complex skin defects of 3-49% TBSA
âś“. Thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated
âś“. Total of both study treatment areas can be up to 2000 cm2
âś“. First excision and grafting of study treatment sites