N/A
Completed N=76
Continued Access to the Recell® Device for Treatment of Acute Burn Injuries
Burns
Source: ClinicalTrials.gov NCT03333941 ↗
Enrolled (actual)
76
Serious AEs
21.1%
Results posted
Jul 2021
Primary outcomePrimary: Percentage of Participants With Wound Healing — 95.3 percentage of participants
Summary
The overall purpose of this continued access study is to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the ReCell® Autologous Cell Harvesting Device is under FDA review. This is a prospective, multicenter, single-arm observational study to evaluate the safety and clinical performance of the ReCell® device when used as an adjunct to meshed autografts in patients with acute thermal burn injuries requiring skin grafting for closure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Wound Healing |
95.3 | — |
Eligibility Criteria
Inclusion Criteria
- The subject requires skin grafting as a result of an acute thermal burn injury (i.e., injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or water).
- The area of total burn injury is 5-50% TBSA inclusive.
- Area(s) requiring skin grafting at least 320 square centimeters.
- The subject is at least 5 years of age.
- The subject (or family, for those under 18 years of age) is willing and able to complete all follow-up evaluations required by the study protocol.
- The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary.
- The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
- The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent.
Exclusion Criteria
- The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances.
- The subject is unable to follow the protocol.
- The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
- The subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
- Pregnant or lactating women.
Data sourced from ClinicalTrials.gov (NCT03333941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.