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Continued Access to the Recell® Device for Treatment of Acute Burn Injuries

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ClinicalTrials.gov Identifier: NCT03333941
Recruitment Status : Completed
First Posted : November 7, 2017
Results First Posted : July 19, 2021
Last Update Posted : July 19, 2021
Sponsor:
Collaborator:
Advanced Clinical Research Services, LLC
Information provided by (Responsible Party):
Avita Medical

Brief Summary:
The overall purpose of this continued access study is to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the ReCell® Autologous Cell Harvesting Device is under FDA review. This is a prospective, multicenter, single-arm observational study to evaluate the safety and clinical performance of the ReCell® device when used as an adjunct to meshed autografts in patients with acute thermal burn injuries requiring skin grafting for closure.

Condition or disease Intervention/treatment
Burns Device: ReCell® Autologous Cell Harvesting Device

Detailed Description:

Patients 5 years or older with a total body surface area (TBSA) thermal burn injury between 5 and 50% (inclusive) who require autografting will be considered for participation in this study. RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting. Healing, scar outcomes, pain and treatment-related adverse events will be evaluated at follow-up visits. Data concerning the clinical performance and safety of the ReCell device will be collected. Safety will be evaluated in terms of treatment and serious related adverse events.

Each subject will participate in up to 7 total visits (treatment visit and 6 follow-up study visits) over a period of 24 weeks. Up to 60 subjects will be enrolled and treated within this study at up to 15 institutions.

It is anticipated that enrollment will continue until PMA approval. Subject follow-up will continue until the last enrolled subject completes the 24-week visit.

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Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Continued Access Protocol: A Prospective, Multicenter, Single-Arm, Observational Study of the Safety and Clinical Performance of RES (Regenerative Epithelial Suspension) Prepared With the ReCell® Device Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries
Actual Study Start Date : October 26, 2017
Actual Primary Completion Date : December 19, 2018
Actual Study Completion Date : May 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Group/Cohort Intervention/treatment
RES (Regenerative Epithelial Suspension) Device: ReCell® Autologous Cell Harvesting Device
RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting.




Primary Outcome Measures :
  1. Wound Healing [ Time Frame: Confirmed by week 8, at two consecutive study visits at least 2 weeks apart up to 24 Weeks (e.g., at week 4 and week 8, or if a visit was missed, week 4 and week 12) ]
    Treatment area will be evaluated via direct visualization by the treating investigator. Complete wound closure is defined as ≥95 to100% re-epithelialization without drainage by week 8.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Burn Unit
Criteria

Inclusion Criteria:

  1. The subject requires skin grafting as a result of an acute thermal burn injury (i.e., injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or water).
  2. The area of total burn injury is 5-50% TBSA inclusive.
  3. Area(s) requiring skin grafting at least 320 square centimeters.
  4. The subject is at least 5 years of age.
  5. The subject (or family, for those under 18 years of age) is willing and able to complete all follow-up evaluations required by the study protocol.
  6. The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary.
  7. The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
  8. The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent.

Exclusion Criteria:

  1. The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances.
  2. The subject is unable to follow the protocol.
  3. The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
  4. The subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
  5. Pregnant or lactating women.

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): NCT03333941


Locations
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United States, Arizona
Arizona Burn Center at Maricopa Integrated Health Systems
Phoenix, Arizona, United States, 85008
United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Louisiana
University Medical Center
New Orleans, Louisiana, United States, 70112
United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38103-3409
Sponsors and Collaborators
Avita Medical
Advanced Clinical Research Services, LLC
  Study Documents (Full-Text)

Documents provided by Avita Medical:
Study Protocol  [PDF] December 19, 2017
Statistical Analysis Plan  [PDF] December 11, 2017

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Responsible Party: Avita Medical
ClinicalTrials.gov Identifier: NCT03333941    
Other Study ID Numbers: CTP001-8
First Posted: November 7, 2017    Key Record Dates
Results First Posted: July 19, 2021
Last Update Posted: July 19, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Burns
Wounds and Injuries