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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02380612
First Posted: March 5, 2015
Last Update Posted: March 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
MedDRA Assistance Inc
Advanced Clinical
Information provided by (Responsible Party):
Avita Medical
  Purpose
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.

Condition Intervention
Burns Device: ReCell Treatment Procedure: Skin Graft

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Avita Medical:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • POSAS [ Time Frame: At 24 Week ]
  • Patient Preference (between ReCell versus control) [ Time Frame: At 24 Week ]

Enrollment: 30
Study Start Date: January 2015
Study Completion Date: February 2017
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Area A
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 Treatment Procedure: Skin Graft
Experimental: 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. Investigational treatment will be randomly allocated to either Area A or Area B
Device: ReCell Treatment Procedure: Skin Graft

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
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 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.
  Contacts and Locations
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): NCT02380612


Locations
United States, Arizona
Arizona Burn Center at Maricopa Medical Center
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
North Carolina Jaycee Burn Center
Chapel Hill, North Carolina, United States, 27599
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
USAISR - US Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
Avita Medical
MedDRA Assistance Inc
Advanced Clinical
Investigators
Principal Investigator: James H Holmes, IV, MD Wake Forest University Health Sciences
  More Information

Responsible Party: Avita Medical
ClinicalTrials.gov Identifier: NCT02380612     History of Changes
Other Study ID Numbers: CTP001-6
First Submitted: February 17, 2015
First Posted: March 5, 2015
Last Update Posted: March 8, 2017
Last Verified: June 2016

Keywords provided by Avita Medical:
Second Degree Burn Injuries

Additional relevant MeSH terms:
Burns
Wounds and Injuries