Clinical trial NCT05517902: StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin Wound
Burns
Trauma-related Wound
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2022-08-26
Enrollment: 1
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Achieved Confirmed Complete Closure of StrataGraft Treatment Sites Without Autograft Within 12 Weeks of StrataGraft Application
timeFrame: Up to Week 12
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Month 12
Secondary outcomes:
measure: Percentage of StrataGraft Treatment Sites Per Participant Closed at Week 12 Without Autograft Placement
timeFrame: At Week 12
measure: Number of Confirmed Complete Wound Closures of the StrataGraft Treatment Sites on or Before Week 12 Without Autograft Placement
timeFrame: Up to Week 12
measure: Mean of Averaged Percent Area of StrataGraft Treatment Sites Per Participant Autografted by Week 12
timeFrame: Up to Week 12
Other outcomes:
Locations:
city: Madison
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Stratatech, a Mallinckrodt Company
name: Clinical Team Leader
role: STUDY_DIRECTOR
References: