Back to resultsCONTINUED 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
Primary Purpose
Burns
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ReCell
Sponsored by
About this trial
This is an interventional treatment trial for Burns
Eligibility Criteria
Inclusion Criteria:
- 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).
- The area of total burn injury is 5-50% TBSA inclusive.
- Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous), excluding hand/face and joints.
- The subject is at least 5 years of age.
- 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.
- The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary.
- The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
- The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent.
Exclusion Criteria:
- The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances.
- The subject is unable to follow the protocol.
- The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
- The subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
- Life expectancy is less than 1year.
Sites / Locations
- Arizona Burn Center at Maricopa Integrated Health Systems
- MedStar Washington Hospital Center
- Tampa General Hospital
- Wake Forest Baptist Medical Center
- University of Tennessee Health Science Center
- U.S.Army Institute of Surgical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ReCell
Control
Arm Description
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
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
Outcomes
Primary Outcome Measures
Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)
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.
Relative Reduction in Donor Skin Area Requirement
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02994654
Brief 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
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 Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avita Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ReCell
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
ReCell
Intervention Description
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 Measure Information:
Title
Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)
Description
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.
Time Frame
Prior to or at 8 weeks
Title
Relative Reduction in Donor Skin Area Requirement
Description
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.
Time Frame
Prior to or at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
The area of total burn injury is 5-50% TBSA inclusive.
Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous), excluding hand/face and joints.
The subject is at least 5 years of age.
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.
The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary.
The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent.
Exclusion Criteria:
The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances.
The subject is unable to follow the protocol.
The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
The subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
Life expectancy is less than 1year.
Facility Information:
Facility Name
Arizona Burn Center at Maricopa Integrated Health Systems
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103-3409
Country
United States
Facility Name
U.S.Army Institute of Surgical Research
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234-7767
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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