StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects

Study Overview
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Brief Summary
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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 is 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 will be 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. The study will last for approximately 2.5 years.

Official Title
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A Phase 3 Multicenter, Single-Arm, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of StrataGraft® Construct in Pediatric Subjects With Deep Partial Thickness (DPT) Thermal Burns

Conditions
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Skin Wound, Burns, Trauma-related Wound

Intervention / Treatment
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* Biological: StrataGraft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent provided by the parent(s) or legal guardian(s) and assent from the child when appropriate Have enough healthy skin to reserve as donor site(s), in case autografting becomes necessary Thermal burns of no more than a total of 30% TBSA Study treatment sites that are DPT in depth and which are clinically indicated for excision and autografting, and located on the torso or extremities Study treatment area(s) totaling 0.5% to 10% TBSA and may be composed of up to 3 non-contiguous areas located on the same extremity or plane of the torso Sufficient healthy skin available and reserved as a donor site in the event that the StrataGraft treatment site requires autografting Exclusion Criteria: Is pregnant or breastfeeding Receiving treatment to suppress the immune system and/or systemic corticosteroids (inhaled corticosteroids are permitted) A known history of malignancy Pre-admission insulin-dependent diabetes Concurrent trauma, conditions, and/or personal situations that, in the opinion of the investigator, may compromise the participant's safety or the study objectives A burn injury that occurred ≥ 14 days prior to planned StrataGraft application Is expected to survive less than 12 months Is participating in another interventional trial, or did within 90 days before enrollment A proposed study treatment site that has been previously excised or autografted; located adjacent to an undebrided/unexcised burn area; demonstrates signs and symptoms of wound infection, per judgement of the clinical investigator; lies across joints or is located on the feet (i.e., distal to the malleolus), hands (distal to the wrist), face, neck, buttocks, perineum, or genitalia

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 to < 12 years Age Group Cohort<br>Participants of age 2 to < 12 years will receive a single application of StrataGraft to 0.5% to 10% total body surface area (TBSA) on Day 1. | Biological: StrataGraft<br>* StrataGraft® Construct<br>|
| Experimental: 12 to ≤ 17 years Age Group Cohort<br>Participants of age 12 to ≤ 17 years will receive a single application of StrataGraft to 0.5% to 10% TBSA on Day 1. | Biological: StrataGraft<br>* StrataGraft® Construct<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving 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 of the wound without drainage observed at 2 consecutive visits at least 2 weeks apart, but no later than Week 20. | Up to 12 weeks | 
| 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 and considered to be related to StrataGraft. TEAEs are defined as those that are not present at start of study treatment or that represent the exacerbation of a pre-existing condition during the treatment-emergent period. The treatment-emergent period is defined as the time from first application of StrataGraft to the end of the study for each participant. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Area of StrataGraft Treatment Sites per Participant Closed at Week 12 Without Autograft Placement | The mean percent area of StrataGraft treatment site closed at Week 12 without autograft placement will be calculated using the percent of the total treatment site re-epithelialized without autografting at Week 12. | Week 12 | 
| Mean Percent Area of StrataGraft Treatment Sites per Participant Autografted by Week 12 | The percent of the total treatment site area autografted will be calculated by using the percent of the total treatment site as the denominator and the area grafted as the numerator to calculate the percentage of the treatment site grafted. | Week 12 | 
| Number of Confirmed Complete Wound Closures of the Strata Graft Treatment Sites on or Before Week 12 Without Autograft Placement |  | Up to Week 12 |