StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects (StrataSTEPS)

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

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.

Study Overview

• Status: Completed
• Conditions: Burns; Skin Wound; Trauma-related Wound
• Intervention / Treatment: Biological: StrataGraft

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2 to < 12 years Age Group Cohort; Single application of StrataGraft to 0.5% to 10% total body surface area (TBSA) on Day 1.	Biological: StrataGraft; StrataGraft® Construct
Experimental: 12 to ≤ 17 years Age Group Cohort; Single application of StrataGraft to 0.5% to 10% TBSA on Day 1.	Biological: StrataGraft; StrataGraft® Construct

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved 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 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.	Up to Week 12
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, 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.	Up to Month 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stratatech, a Mallinckrodt Company
• Collaborators: Biomedical Advanced Research and Development Authority
• Investigators: Study Director: Clinical Team Leader, Stratatech, a Mallinckrodt Company

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2023
• Primary Completion (Actual): May 9, 2024
• Study Completion (Actual): May 9, 2024

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: MNK15011001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No