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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 is a Phase 1 study that was terminated before completion, run by Stratatech, a Mallinckrodt Company. The registered enrollment target is 13 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04765202
The ClinicalTrials.gov registry entry for NCT04765202 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stratatech, a Mallinckrodt Company, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which AG Tx is the first listed.
NCT04765202 reports 0 study locations.
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.
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