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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Maricopa Integrated Health Systems, Arizona Burn Center
Phoenix, Arizona, United States
University of Colorado Hospital Burn Center
Aurora, Colorado, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
UT-Southwestern Medical Center
Dallas, Texas, United States
U.S. Army Institute of Surgical Research
Fort Sam Houston, Texas, United States
University of Wisconsin Hospital
Madison, Wisconsin, United States
Number of Participants With Wound Closure of the Treatment Sites at Three Months
Determination of complete wound closure of both treatment sites was evaluated at 3 months.
Time frame: 3 months
Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28
The percentage of the treatment site area initially covered with StrataGraft tissue that required autograft by day 28 was determined.
Time frame: 28 days
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