StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III Open-label, Controlled, Randomized, Multicenter Study Evaluating the Efficacy and Safety of StrataGraft Skin Tissue in Promoting Autologous Skin Tissue Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements and for Which Excision and Autografts Are Clinically Indicated

Conditions
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Burn, Thermal

Intervention / Treatment
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* Biological: StrataGraft Skin Tissue
* Procedure: Autograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subject-specific 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 Total burn may consist of more than one area Treatment site-specific criteria: 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 First excision and grafting of study treatment sites Thermal burn(s) on the torso, arms, or legs Exclusion Criteria Subject-specific criteria: Pregnant women Prisoners Subjects receiving systemic immunosuppressive therapy Subjects with a known history of malignancy Preadmission insulin-dependent diabetic subjects Subjects with concurrent conditions that in the opinion of the investigator may compromise subject safety or study objectives Expected survival of less than three months Participation in the treatment group of an interventional study within 90 days prior to enrollment Treatment site-specific criteria: Full-thickness burns Chronic wounds The face, head, neck, hands, feet, buttocks, and area over joints Treatment sites immediately adjacent to unexcised eschar Clinical or laboratory determination of infection at the anticipated treatment sites

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: See detailed description
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: StrataGraft Skin Tissue<br> | Biological: StrataGraft Skin Tissue<br>* StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).<br>Procedure: Autograft<br>* The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Area of Treatment Sites Requiring Autografting by Month 3 | Percent area autografted by Month 3 is the sum of the percent areas at each study session/visit, up to and including Study Session 7/Month 3 (± 14 d). | 3 Months | 
| Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3) | Wound closure of the treatment site was defined as complete skin re-epithelialization and the absence of drainage. A participant whose StrataGraft treatment site achieves durable wound closure without autograft placement is classified as a responder. | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at the Designated Donor Sites by Day 14 | Pain scores from the FACES scale range from 0 (no pain) to 5 (worst pain). Pain scores from Day 3, Day 7, and Day 14 (where available) are averaged for the summary statistics. | Day 3, Day 7 and Day 14, average of the 3 days reported | 
| Total Scar Assessment (POSAS) Score by Observer at Month 3 | Total Score is the sum of the scores for vascularization, pigmentation, thickness, relief, pliability, and surface area. For each of the 6 assessment categories, the scale ranged from 1=normal skin to 10=worst scar imaginable, with the highest possible score of 10. A higher score indicates worse scarring, so the best possible total score for the 6 categories is 6, and the worst possible score is 60. | at Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trauma-related wound, Deep partial thickness, Skin wound