Trials / Completed
CompletedNCT02992249
Prospective Evaluation of the ReCell® Autologous Cell Harvesting Device For Specific Compassionate Use Cases
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- Avita Medical · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This is a prospective uncontrolled observational study to evaluate clinical outcomes following use of the ReCell Autologous Cell Harvesting Device (ReCell) as an adjunct for closure (re-epithelialization) as a treatment of life-threatening wounds requiring grafting for closure, and associated skin graft donor sites, in patients who lack adequate available skin to harvest for conventional grafting. Treatment with the ReCell device may be performed as part of a single operative procedure, or multiple staged procedures as deemed clinically necessary. Adverse events associated with the use of the ReCell device/cell suspension will be documented. Subjects will be followed for 1 year following ReCell treatment.
Conditions
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2019-05-01
- Completion
- 2020-06-01
- First posted
- 2016-12-14
- Last updated
- 2020-08-03
Locations
22 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02992249. Inclusion in this directory is not an endorsement.