Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05517902 · ClinicalTrials.gov registry record · Phase 3

StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects

A Phase 3 study of Burns and Skin Wound, sponsored by Stratatech, a Mallinckrodt Company.

Completed
Registry status
Phase 3
Development phase
1
Enrollment target
1
Study location

NCT05517902: Completed Phase 3 study of Burns and Skin Wound, sponsored by Stratatech, a Mallinckrodt Company.

NCT05517902 is a Phase 3 study of Burns and Skin Wound that has completed, run by Stratatech, a Mallinckrodt Company. The registered enrollment target is 1 participants, below the 83-participant average among 36 other Burns trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05517902, a Phase 3 study of Burns and Skin Wound, has completed, sponsored by Stratatech, a Mallinckrodt Company.

COMPLETED
Registry status
Phase 3
Development phase
1 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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.

Conditions Studied

Burns Skin Wound Trauma-related Wound

Interventions

  • BIOLOGICAL StrataGraft

Study Locations (1)

Wisconsin

  • Research Site - Madison

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2023-04-28
Est. Completion 2024-05-09
Phase Phase 3
Stratatech, a Mallinckrodt Company

9 total trials

What the finished NCT05517902 record still lists

NCT05517902 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 83-participant average among 36 other Burns trials with a reported enrollment target (99% lower).

The record links to 3 conditions, with Burns appearing as the primary indexed condition, and to 1 intervention - of which StrataGraft is the first listed.

NCT05517902 reports a single indexed study location in Wisconsin.

Frequently Asked Questions

What is clinical trial NCT05517902 about?

NCT05517902 is a clinical study titled "StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects". 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...

What is the current status of trial NCT05517902?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2023-04-28. Estimated completion is 2024-05-09.

What conditions does trial NCT05517902 study?

This clinical trial studies the following conditions: Burns, Skin Wound, Trauma-related Wound.

What interventions are being tested in trial NCT05517902?

The interventions under investigation include: StrataGraft (BIOLOGICAL).

Who is sponsoring clinical trial NCT05517902?

This trial is sponsored by Stratatech, a Mallinckrodt Company, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05517902 being conducted?

This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Burns

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05517902's enrollment target sits among peer trials

1 36th of 36 the lowest of 36 other Burns trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Burns trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT05517902, the US trial registry maintained by the National Library of Medicine. NCT05517902 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.