Trials / Completed
CompletedNCT04091672
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of the RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- Avita Medical · Industry
- Sex
- All
- Age
- 5 Years
- Healthy volunteers
- Not accepted
Summary
A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.
Conditions
- Full-thickness Skin Defects
- Degloving Injuries
- Crush Injuries
- Laceration of Skin
- Surgical Wound
- Skin Cancer
- Cellulitis
- Infection
- Necrotizing Fasciitis
- Gun Shot Wound
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Control Intervention (Conventional Autograft) | Meshed split-thickness skin graft, with standardized wound dressings (Telfa™ Clear and Xeroform™) |
| DEVICE | Investigational Intervention (RECELL + more widely meshed autograft) | More widely meshed split-thickness skin graft, Spray-on Skin™ Cells prepared using RECELL, and standardized wound dressings (Telfa™ Clear and Xeroform™) |
Timeline
- Start date
- 2020-03-02
- Primary completion
- 2022-03-07
- Completion
- 2023-02-02
- First posted
- 2019-09-17
- Last updated
- 2024-07-30
- Results posted
- 2023-09-21
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04091672. Inclusion in this directory is not an endorsement.