Summary

at San Diego, California and other locations
study started

Description

Summary

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.

Keywords

Burns

Eligibility

You can join if…

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California San Diego Regional Burn Center accepting new patients
    San Diego, California, 92103-8896, United States
  • Arizona Burn Center at Maricopa Integrated Health Systems accepting new patients
    Phoenix, Arizona, 85008, United States
  • U.S.Army Institute of Surgical Research accepting new patients
    Fort Sam Houston, Texas, 78234-7767, United States
  • Baton Rouge General Regional Burn Center accepting new patients
    Baton Rouge, Louisiana, 70809, United States
  • University of Tennessee Health Science Center accepting new patients
    Memphis, Tennessee, 38103-3409, United States
  • University of South Alabama Department of Surgery accepting new patients
    Mobile, Alabama, 36688, United States
  • Richard M. Fairbanks Burn Center at Eskenazi Health accepting new patients
    Indianapolis, Indiana, 46202, United States
  • Wake Forest University Health Sciences accepting new patients
    Winston-Salem, North Carolina, 27157, United States
  • Walter Reed National Military Medical Center Bethesda accepting new patients
    Bethesda, Maryland, 20889, United States
  • MedStar Washington Hospital Center accepting new patients
    Washington, District of Columbia, 20010, United States
  • St. Christopher's Hospital for Children accepting new patients
    Philadelphia, Pennsylvania, 19134, United States
  • Massachusetts General Hospital accepting new patients
    Boston, Massachusetts, 02114, United States
  • Shriner's Boston accepting new patients
    Boston, Massachusetts, 02114, United States

Details

Status
accepting new patients
Start Date
Sponsor
Avita Medical
ID
NCT02992249
Study Type
Observational
Last Updated
January 18, 2018