NCT05517902

StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Stratatech, a Mallinckrodt Company · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	StrataGraft	StrataGraft® Construct

Timeline

• Start date: 2023-04-28
• Primary completion: 2024-05-09
• Completion: 2024-05-09
• First posted: 2022-08-26
• Last updated: 2025-03-18
• Results posted: 2025-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study