Trials / Terminated
TerminatedNCT03624192
RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites 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 Conventional Care for Healing of Donor Sites in Infants, Children and Adolescents (Aged 1-16 Years)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Avita Medical · Industry
- Sex
- All
- Age
- 1 Year – 16 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate whether the time to complete closure is superior for RECELL-treated split-thickness donor sites, compared with Control (standardized dressings only). The mean time for donor site healing will be compared between treatments.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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 |
| OTHER | Telfa™ Clear and Xeroform™ dressings | Telfa™ Clear and Xeroform™ dressings |
Timeline
- Start date
- 2018-09-19
- Primary completion
- 2020-01-13
- Completion
- 2020-01-13
- First posted
- 2018-08-10
- Last updated
- 2024-07-18
- Results posted
- 2021-07-28
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03624192. Inclusion in this directory is not an endorsement.