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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: Completed NA study, sponsored by Avita Medical.
NCT02380612 is a NA study that has completed, run by Avita Medical. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Complete wound closure is defined as skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for RECELL-treated areas as compared to control areas.
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 |
What the finished NCT02380612 record still lists
NCT02380612 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which ReCell Treatment is the first listed.
NCT02380612 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02380612's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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