StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns

Phase 1

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
StrataGraft skin tissue	StrataGraft Skin Tissue	All subjects enrolled in this study will receive StrataGraft tissue. Will randomly assign treatment regimens to the two comparable study treatment sites pre-identified as A or B. A sealed randomization envelope will be supplied to the clinical site along with the shipment of clinical tissue. Neither the surgeon nor scrubbed operating room personnel will be informed of the randomization until completion of surgical excision. The treatment sites A or B will be randomized to receive either StrataGraft skin tissue or autograft using a 1:1 ratio. Two comparable areas of healthy skin will be pre-identified by the clinical staff as donor sites A or B. The randomization assignment will be identical as that above for the treatment sites. For example, if treatment site A is randomized to receive an autograft, donor site A will be designated the donor site for autografting

Primary Outcome Measures

Name	Time	Method
Number of Participants With Wound Closure of the Treatment Sites at Three Months	3 months	Determination of complete wound closure of both treatment sites was evaluated at 3 months.
Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28	28 days	The percentage of the treatment site area initially covered with StrataGraft tissue that required autograft by day 28 was determined.

Secondary Outcome Measures

Name	Time	Method

Locations (6): Maricopa Integrated Health Systems, Arizona Burn Center
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Phoenix, Arizona, United States
University of Wisconsin Hospital
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Madison, Wisconsin, United States
Wake Forest University Baptist Medical Center
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Winston-Salem, North Carolina, United States
University of Colorado Hospital Burn Center
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Aurora, Colorado, United States
UT-Southwestern Medical Center
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Dallas, Texas, United States
U.S. Army Institute of Surgical Research
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Fort Sam Houston, Texas, United States