StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects

NCT ID: NCT05517902

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-28
• Study Completion Date: 2024-05-09

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2 to < 12 years Age Group Cohort

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

Group Type: EXPERIMENTAL

StrataGraft

Intervention Type: BIOLOGICAL

StrataGraft® Construct

12 to ≤ 17 years Age Group Cohort

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

Group Type: EXPERIMENTAL

StrataGraft

Intervention Type: BIOLOGICAL

StrataGraft® Construct

Interventions

StrataGraft

StrataGraft® Construct

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biomedical Advanced Research and Development Authority

FED

Sponsor Role: collaborator

Stratatech, a Mallinckrodt Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Team Leader

Role: STUDY_DIRECTOR

Stratatech, a Mallinckrodt Company

Locations

Research Site

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Statistical Analysis Plan: Statistical Analysis Plan_Memo

View Document

Other Identifiers

MNK15011001

Identifier Type: -

Identifier Source: org_study_id