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NCT02380612 · ClinicalTrials.gov registry record · NA
ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries
A NA study, sponsored by Avita Medical.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT02380612 is a NA study that has completed, run by Avita Medical. The registered enrollment target is 30 participants.
The verdict
NCT02380612, a NA study, has completed, sponsored by Avita Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a randomized, within-subject controlled study to compare the clinical performance of the ReCell device when used as an adjunct to meshed skin graft in subjects requiring skin grafts for closure of burn injuries. Co-primary effectiveness endpoints include: (1) confirmed treatment area closure (i.e., healing) prior to or at 8 weeks as assessed by a blinded evaluator, and (2) a comparison of the actual expansion ratio, computed as the ratio of measured treated area to the measured donor site area, achieved for the ReCell-treated and control treatment areas. Safety will be evaluated in terms of long-term durability, scar outcomes and treatment-related adverse events.
Interventions
- DEVICE ReCell Treatment
- PROCEDURE Skin Graft
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-01-26 |
| Est. Completion | 2017-02-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02380612
The ClinicalTrials.gov registry entry for NCT02380612 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Avita Medical, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ReCell Treatment is the first listed.
NCT02380612 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02380612 about?
NCT02380612 is a clinical study titled "ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries". This is a randomized, within-subject controlled study to compare the clinical performance of the ReCell device when used as an adjunct to meshed skin graft in subjects requiring skin grafts for closure of burn injuries. Co-primary effectiveness endpoints include: (1) confirmed treatment area closure...
What is the current status of trial NCT02380612?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2015-01-26. Estimated completion is 2017-02-01.
What interventions are being tested in trial NCT02380612?
The interventions under investigation include: ReCell Treatment (DEVICE), Skin Graft (PROCEDURE).
Who is sponsoring clinical trial NCT02380612?
This trial is sponsored by Avita Medical, which has 13 total clinical trials registered on ClinicalTrials.gov.
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