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

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ClinicalTrials.gov Identifier: NCT02992249
Recruitment Status : Active, not recruiting
First Posted : December 14, 2016
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Avita Medical

Brief 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.

Condition or disease
Burns

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Study Type : Observational
Estimated Enrollment : 108 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : May 2014
Estimated Primary Completion Date : February 2019



Primary Outcome Measures :
  1. Wound Healing [ Time Frame: 28 days ]
    > 95% epithelialization with a contiguous layer of viable epithelium



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02992249


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Sponsors and Collaborators
Avita Medical

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Responsible Party: Avita Medical
ClinicalTrials.gov Identifier: NCT02992249     History of Changes
Other Study ID Numbers: CTP004
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No