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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
StrataGraft® Construct
Research Site
Madison, Wisconsin, United States
Percentage of Participants Who Achieved Confirmed Complete Closure of StrataGraft Treatment Sites Without Autograft Within 12 Weeks of StrataGraft Application
Confirmed complete wound closure is defined as complete skin re-epithelialization confirmed at 2 consecutive visits at least 2 weeks apart, but no later than Week 20. Percentage of participants whose burn healed after StrataGraft treatment without needing the doctor to treat the burn with skin cut from other parts of the patient's own body were reported.
Time frame: Up to Week 12
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant who is administered a study treatment, which does not necessarily have to have a causal relationship with this treatment. TEAEs are AEs with an onset date on or after the start of StrataGraft treatment.
Time frame: Up to Month 12
Percentage of StrataGraft Treatment Sites Per Participant Closed at Week 12 Without Autograft Placement
Wound closure was evaluated through visual inspection by the investigator. Complete wound closure was defined as "complete re-epithelialization of the wound without drainage," confirmed at 2 consecutive visits at least 2 weeks apart.
Time frame: At Week 12
Number of Confirmed Complete Wound Closures of the StrataGraft Treatment Sites on or Before Week 12 Without Autograft Placement
Complete wound closure was defined as "complete re-epithelialization of the wound without drainage," confirmed at two consecutive visits at least two weeks apart.
Time frame: Up to Week 12
Mean of Averaged Percent Area of StrataGraft Treatment Sites Per Participant Autografted by Week 12
Time frame: Up to Week 12
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