StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
12 to ≤ 17 years Age Group Cohort	StrataGraft	Participants of age 12 to ≤ 17 years will receive a single application of StrataGraft to 0.5% to 10% TBSA on Day 1.
2 to < 12 years Age Group Cohort	StrataGraft	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.
2 to < 12 years Age Group Cohort	StrataGraft	Single application of StrataGraft to 0.5% to 10% total body surface area (TBSA) on Day 1.
12 to ≤ 17 years Age Group Cohort	StrataGraft	Single application of StrataGraft to 0.5% to 10% TBSA on Day 1.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Confirmed Complete Closure of StrataGraft Treatment Sites Without Autograft Within 12 Weeks of StrataGraft Application	Up to Week 12	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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Up to Month 12	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of StrataGraft Treatment Sites Per Participant Closed at Week 12 Without Autograft Placement	At Week 12	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.
Number of Confirmed Complete Wound Closures of the StrataGraft Treatment Sites on or Before Week 12 Without Autograft Placement	Up to Week 12	Complete wound closure was defined as "complete re-epithelialization of the wound without drainage," confirmed at two consecutive visits at least two weeks apart.
Mean of Averaged Percent Area of StrataGraft Treatment Sites Per Participant Autografted by Week 12	Up to Week 12