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NCT04123548 · ClinicalTrials.gov registry record · Phase 3
StrataGraft® Skin Tissue Expanded Access at Specific Study Sites ( StrataCAT )
A Phase 3 study, sponsored by Stratatech, a Mallinckrodt Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 52
- Enrollment target
NCT04123548 is a Phase 3 study that has completed, run by Stratatech, a Mallinckrodt Company. The registered enrollment target is 52 participants.
The verdict
NCT04123548, a Phase 3 study, has completed, sponsored by Stratatech, a Mallinckrodt Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 52 participants
- Enrollment target
Study Summary
An autograft is a piece of skin taken from a healthy area of the body to be used to treat severe burns on another part of the same body. StrataGraft skin tissue was an investigational tissue that could be used as an alternative to an autograft. * StrataGraft skin tissue was in late-stage clinical development for the treatment of adults with deep partial-thickness (DPT) burns. * There were no safety concerns reported to date. The sponsor submitted a treatment protocol to Food and Drug Administration (FDA) for doctors who participated in the Phase 3 Strata 2016 study (NCT 03005106) to allow for expanded access to StrataGraft before it was commercially available. The main purpose of the study was to allow patients to receive StrataGraft during Biologics License Application review and prior to approval by the FDA for the treatment of DPT burns. The primary outcome measure was the number of participants with adverse events and safety concerns.
Interventions
- BIOLOGICAL StrataGraft skin tissue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2020-02-18 |
| Est. Completion | 2022-01-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04123548
The ClinicalTrials.gov registry entry for NCT04123548 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 52 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 1 intervention - of which StrataGraft skin tissue is the first listed.
NCT04123548 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04123548 about?
NCT04123548 is a clinical study titled "StrataGraft® Skin Tissue Expanded Access at Specific Study Sites ( StrataCAT )". An autograft is a piece of skin taken from a healthy area of the body to be used to treat severe burns on another part of the same body. StrataGraft skin tissue was an investigational tissue that could be used as an alternative to an autograft. * StrataGraft skin tissue was in late-stage clinical ...
What is the current status of trial NCT04123548?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 52 participants. The study started on 2020-02-18. Estimated completion is 2022-01-26.
What interventions are being tested in trial NCT04123548?
The interventions under investigation include: StrataGraft skin tissue (BIOLOGICAL).
Who is sponsoring clinical trial NCT04123548?
This trial is sponsored by Stratatech, a Mallinckrodt Company, which has 9 total clinical trials registered on ClinicalTrials.gov.
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