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. IRB Number 16-178
SponsorsThis trial is sponsored by Avita Medical.
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Providers Associated With This Trial
- Sidney B. Brevard, M.D., M.P.H., F.A.C.S.Trauma/Critical Care SurgeonDirector of the Division of Acute Care Surgery and Burns; Program Director for Surgical Critical Care Fellowship; Professor of Surgery