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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 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.
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.
Conditions Studied
Interventions
- BIOLOGICAL StrataGraft
Study Locations (1)
Wisconsin
- Research Site - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2023-04-28 |
| Est. Completion | 2024-05-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05517902
The ClinicalTrials.gov registry entry for NCT05517902 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 83-participant average among 36 other Burns trials with a reported enrollment target (99% lower). The listed sponsor is Stratatech, a Mallinckrodt Company, which has 9 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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