StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects

NCT05517902 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: MNK15011001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Wound; Burns; Trauma-related Wound

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Percentage of StrataGraft Treatment Sites Per Participant Closed at Week 12 Without Autograft Placement

  At Week 12

• Number of Confirmed Complete Wound Closures of the StrataGraft Treatment Sites on or Before Week 12 Without Autograft Placement

  Up to Week 12

• Mean of Averaged Percent Area of StrataGraft Treatment Sites Per Participant Autografted by Week 12

  Up to Week 12

Study Arms (2)

2 to < 12 years Age Group Cohort

EXPERIMENTAL

Single application of StrataGraft to 0.5% to 10% total body surface area (TBSA) on Day 1.

Biological: StrataGraft

12 to ≤ 17 years Age Group Cohort

EXPERIMENTAL

Single application of StrataGraft to 0.5% to 10% TBSA on Day 1.

Biological: StrataGraft

Interventions

StrataGraft BIOLOGICAL

StrataGraft® Construct

12 to ≤ 17 years Age Group Cohort; 2 to < 12 years Age Group Cohort

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stratatech, a Mallinckrodt Company: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (1)

Research Site

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Limitations and Caveats

This study had low accrual and only 1 participant was enrolled.

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Mallinckrodt

medinfo@mnk.com

1-800-844-2830

Study Officials

• Clinical Team Leader

  Stratatech, a Mallinckrodt Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: April 28, 2023
• Primary Completion: May 9, 2024
• Study Completion: May 9, 2024
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)