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NCT04765202 · ClinicalTrials.gov registry record · Phase 1
StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns
A Phase 1 study, sponsored by Stratatech, a Mallinckrodt Company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT04765202: Clinical Trial Phase 1 study, sponsored by Stratatech, a Mallinckrodt Company.
NCT04765202 is a Phase 1 study that was terminated before completion, run by Stratatech, a Mallinckrodt Company. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04765202, a Phase 1 study, was terminated before completion, sponsored by Stratatech, a Mallinckrodt Company.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
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 full-thickness (FT) 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 FT wounds themselves * Treatment problems can require more grafting * Additional surgery increases risk of medical problems caused by the treatment Stratatech is trying to find a safe and effective treatment option for severe burns that uses less donor skin. All participants in this study received meshed autograft on one part of their burn (AG Tx). They received more widely meshed than AG Tx site autograft with a StrataGraft covering (SOMA Tx) on a different part of their burn.
Primary Outcome
Confirmed complete wound closure was defined as complete skin re-epithelialization without drainage confirmed at 2 visits at least 2 weeks apart but no later than Week 20. Complete wound closure was considered to have occurred at the earlier of the 2 observations of complete skin re-epithelialization without drainage. The number of treatment sites with complete wound closure without additional autografting at Month 2 was reported.
Interventions
- PROCEDURE AG Tx
- BIOLOGICAL SOMA Tx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-10-10 |
| Est. Completion | 2024-06-07 |
| Phase | Phase 1 |
Why NCT04765202 stopped before completion
NCT04765202 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which AG Tx is the first listed.
NCT04765202 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04765202 about?
NCT04765202 is a clinical study titled "StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns". 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 full-thickness (FT) burns. It works to close the wound, but can cause other problems: * Donor sites ...
What is the current status of trial NCT04765202?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2021-10-10. Estimated completion is 2024-06-07.
What interventions are being tested in trial NCT04765202?
The interventions under investigation include: AG Tx (PROCEDURE), SOMA Tx (BIOLOGICAL).
Who is sponsoring clinical trial NCT04765202?
This trial is sponsored by Stratatech, a Mallinckrodt Company, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04765202's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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