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OpenTrials
Completed

NCT Number: NCT02992249

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

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.

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Key information

Conditions

Burns Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

University of South Alabama Department of Surgery, Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Wound Healing

    Time frame: Wound healing assessed at all study visits

    > 95% epithelialization with a contiguous layer of viable epithelium

Sponsors and collaborators

Lead sponsor

Avita Medical

Industry

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Dec 14, 2016
Registry last updated
Aug 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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