Trials / Completed
CompletedNCT02380612
ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries
Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Avita Medical · Industry
- Sex
- All
- Age
- 5 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ReCell Treatment | |
| PROCEDURE | Skin Graft |
Timeline
- Start date
- 2015-01-26
- Primary completion
- 2016-01-21
- Completion
- 2017-02-01
- First posted
- 2015-03-05
- Last updated
- 2025-01-07
- Results posted
- 2021-02-23
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02380612. Inclusion in this directory is not an endorsement.