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ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries

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ClinicalTrials.gov Identifier: NCT02380612
Recruitment Status : Completed
First Posted : March 5, 2015
Results First Posted : February 23, 2021
Last Update Posted : February 23, 2021
Sponsor:
Collaborators:
MedDRA Assistance Inc
Advanced Clinical Research Services, LLC
Information provided by (Responsible Party):
Avita Medical

Tracking Information
First Submitted Date  ICMJE February 17, 2015
First Posted Date  ICMJE March 5, 2015
Results First Submitted Date  ICMJE September 25, 2018
Results First Posted Date  ICMJE February 23, 2021
Last Update Posted Date February 23, 2021
Actual Study Start Date  ICMJE January 26, 2015
Actual Primary Completion Date January 21, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2021)
  • 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.
  • Actual Expansion Ratios (Treatment Area to Donor Site Area, Inclusive of Donor Skin Needed for Secondary Treatments) [ 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2015)
  • Confirmed Treatment Area Closure [ 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.
  • The actual expansion ratios (treatment area to donor site area, inclusive of donor skin needed for secondary treatments) will be calculated separately for the ReCell and control treatments. [ 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2021)
  • Observer Overall Patient and Observer Scar Assessment Scale ( POSAS) Opinion Score [ Time Frame: At 24 Week ]
    The observer component of the Patient and Observer Scar Assessment Scale (POSAS) questionnaire required the blinded evaluator to provide an overall opinion of the treatment area compared to normal skin, scored from 1 (normal skin) to 10 (worst imaginable scar).
  • Patient's Satisfaction/Treatment Preference [ Time Frame: At 24 Week ]
  • Patient Overall Patient and Observer Scar Assessment Scale (POSAS) Opinion Score [ Time Frame: Week 24 ]
    The patient component of the Patient Overall Patient and Observer Scar Assessment Scale (POSAS) questionnaire required the patient to provide an overall opinion of the treatment area compared to normal skin, scored from 1 (normal skin) to 10 (worst imaginable scar). T
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2015)
  • POSAS [ Time Frame: At 24 Week ]
  • Patient Preference (between ReCell versus control) [ Time Frame: At 24 Week ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries
Official Title  ICMJE 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
Brief Summary This is a randomized, within-subject controlled study to compare the clinical performance of the ReCell device when used as an adjunct to meshed skin graft in subjects requiring skin grafts for closure of burn injuries. Co-primary effectiveness endpoints include: (1) confirmed treatment area closure (i.e., healing) prior to or at 8 weeks as assessed by a blinded evaluator, and (2) a comparison of the actual expansion ratio, computed as the ratio of measured treated area to the measured donor site area, achieved for the ReCell-treated and control treatment areas. Safety will be evaluated in terms of long-term durability, scar outcomes and treatment-related adverse events.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
The participant and blinded evaluator will be not be told which treatment area received which treatment (RECELL or Control).
Primary Purpose: Treatment
Condition  ICMJE Burns
Intervention  ICMJE
  • Device: ReCell Treatment
  • Procedure: Skin Graft
Study Arms  ICMJE Experimental: All Participants (within patient 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. Investigational treatment will be randomly allocated to either Area A or Area B
Interventions:
  • Device: ReCell Treatment
  • Procedure: Skin Graft
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 1, 2017
Actual Primary Completion Date January 21, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 followup 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 1 year.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02380612
Other Study ID Numbers  ICMJE CTP001-6
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avita Medical
Study Sponsor  ICMJE Avita Medical
Collaborators  ICMJE
  • MedDRA Assistance Inc
  • Advanced Clinical Research Services, LLC
Investigators  ICMJE
Principal Investigator: James H Holmes, IV, MD Wake Forest University Health Sciences
PRS Account Avita Medical
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP