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CONTINUED ACCESS PROTOCOL: Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries

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ClinicalTrials.gov Identifier: NCT02994654
Recruitment Status : Completed
First Posted : December 16, 2016
Results First Posted : May 4, 2021
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Avita Medical

Brief Summary:
The overall purpose of this is study to provide continued access to the ReCell device following completion of protocol CTP001-6, and allow for collection of supplementary clinical outcome data for the ReCell device when used as an adjunct to meshed grafts in subjects with acute thermal burn injuries who require skin grafting for closure of burn injuries.

Condition or disease Intervention/treatment Phase
Burns Device: ReCell Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CONTINUED ACCESS PROTOCOL: Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries
Study Start Date : October 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Experimental: ReCell
All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B
Device: ReCell

The ReCell-assigned treatment area will be treated as described in the product's Instructions for Use. In summary, 1ml of fluid physically covers a treatment area of 80 cm2. Each milliliter of fluid contains cells harvested from a square centimeter of thin split-thickness skin sample.

The reagents and components of the ReCell kit are used, in a scalable fashion, to facilitate disaggregation of cells from skin samples into filtered cell suspension. Areas to be harvested for skin samples are to be clean and show no evidence of surrounding cellulitis or infection. Treatment area sizes and cell suspension volumes are to be recorded.


Experimental: Control
All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Control, which is the Investigator's pre-determined graft plan will be randomly allocated to either Area A or Area B
Device: ReCell

The ReCell-assigned treatment area will be treated as described in the product's Instructions for Use. In summary, 1ml of fluid physically covers a treatment area of 80 cm2. Each milliliter of fluid contains cells harvested from a square centimeter of thin split-thickness skin sample.

The reagents and components of the ReCell kit are used, in a scalable fashion, to facilitate disaggregation of cells from skin samples into filtered cell suspension. Areas to be harvested for skin samples are to be clean and show no evidence of surrounding cellulitis or infection. Treatment area sizes and cell suspension volumes are to be recorded.





Primary Outcome Measures :
  1. Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority) [ Time Frame: Prior to or at 8 weeks ]
    Complete wound closure is defined as skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for ReCell-treated areas as compared to control areas.

  2. Relative Reduction in Donor Skin Area Requirement [ Time Frame: Prior to or at 8 weeks ]
    For this second co-primary endpoint, it is hypothesized that the expansion ratio associated with the RECELL treatment area will be superior to that of the control, i.e. less donor skin will be required for RECELL-treated areas compared with the control areas.



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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
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. Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous), excluding hand/face and joints.
  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. Life expectancy is less than 1year.

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): NCT02994654


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, 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
United States, Texas
U.S.Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234-7767
Sponsors and Collaborators
Avita Medical
  Study Documents (Full-Text)

Documents provided by Avita Medical:
Statistical Analysis Plan  [PDF] May 7, 2018

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Responsible Party: Avita Medical
ClinicalTrials.gov Identifier: NCT02994654    
Other Study ID Numbers: CTP001-7
First Posted: December 16, 2016    Key Record Dates
Results First Posted: May 4, 2021
Last Update Posted: May 4, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Burns
Wounds and Injuries