Continued Access to the Recell® Device for Treatment of Acute Burn Injuries (NCT03333941) | Clinical Trial Compass
CompletedNot Applicable
Continued Access to the Recell® Device for Treatment of Acute Burn Injuries
United States76 participantsStarted 2017-10-26
Plain-language 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.
Who can participate
Age range5 Years
SexALL
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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.
✕
What they're measuring
1
Percentage of Participants With Wound Healing
Timeframe: Confirmed by week 8, at two consecutive study visits at least 2 weeks apart up to 24 Weeks (e.g., at week 4 and week 8, or if a visit was missed, week 4 and week 12)