Trials / Terminated
TerminatedNCT03626701
RES® Prepared With RECELL® Compared to Standard of Care Dressings of Partial-thickness Burns in Ages 1-16 Years
A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RES® (Regenerative Epidermal Suspension) Prepared With the RECELL® Device Compared to Standard of Care Dressings for Treatment of Partial-thickness Burns in Infants, Children and Adolescents (Aged 1-16 Years)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Avita Medical · Industry
- Sex
- All
- Age
- 1 Year – 16 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, parallel-arm, randomized (1:1) multicenter trial to demonstrate that RECELL treatment of partial-thickness burn injuries, can safely and effectively increase the incidence of Day 10 healing compared with a standardized wound dressing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device | Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings. |
| COMBINATION_PRODUCT | Mepilex® Ag Wound Dressing | Application of Mepilex® Ag Wound Dressing |
| PROCEDURE | Conventional autografting (only when indicated) | When indicated, conventional autografting in accordance with Investigator's standard practice |
Timeline
- Start date
- 2020-03-03
- Primary completion
- 2021-06-23
- Completion
- 2022-06-03
- First posted
- 2018-08-13
- Last updated
- 2024-07-30
- Results posted
- 2023-06-26
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03626701. Inclusion in this directory is not an endorsement.