Prospective Evaluation of the ReCell® Autologous Cell Harvesting Device For Specific Compassionate Use Cases

AVITA Medical

Status: Completed

Conditions: Burns

Study type: Observational

Funder types: Industry

Identifiers

NCT02992249

CTP004

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient requires treatment of a life-threatening wound requiring grafting.
• Patient has inadequate available skin to harvest for conventional skin grafting.
• The treating investigator has determined 1) that there is no suitable alternative therapy that would be adequate to meet the patient's medical need; and 2) the risk associated with use of the ReCell device is no greater than the probable risk from the disease or condition.
• In the treating investigator's opinion and with consideration of the severity of the patient's health status, the patient has the potential to realize benefits from the application of the ReCell device.
• Patient is hemodynamically stable.
• The patient (or legal representative) is able to read and understand instructions and give informed consent.

Exclusion criteria

• The patient has active infection at the proposed ReCell treatment site.
• The patient is unable to follow the protocol.
• The patient has a known hypersensitivity to trypsin or Compound Sodium Lactate for Irrigation (Hartmann's) solution.