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RES Prepared With RECELL® Compared to Standard of Care Dressings of Partial-thickness Burns in Ages 1-16 Years

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03626701
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : March 12, 2020
Sponsor:
Collaborator:
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
Avita Medical

Brief Summary:
A prospective, parallel-arm, randomized (1:1) multicenter trial to demonstrate that application of autologous skin cell suspension (RES) prepared using the RECELL® device can be safely and effectively used to reduce the incidence of conventional autografting and healing time of partial-thickness burns when compared with a standardized, conventional wound dressing.

Condition or disease Intervention/treatment Phase
Burns Device: RECELL® Autologous Cell Harvesting Device Combination Product: Mepilex® Wound Dressing Procedure: Conventional autografting (only when indicated) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
  1. Blinded Evaluator/Observer - local burn specialist
  2. Independent Reviewer
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RES (Regenerative Epidermal Suspension) Prepared With the RECELL® Device Compared to Standard of Care Dressings for Treatment of Partial-thickness Burns in Infants, Children and Adolescents (Aged 1-16 Years)
Actual Study Start Date : March 3, 2020
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RECELL® Autologous Cell Harvesting Device

RECELL + Telfa™ Clear and Xeroform™ dressings

Conventional autografting (only when indicated)

Device: RECELL® Autologous Cell Harvesting Device
Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings.
Other Name: RES (Regenerative Epidermal Suspension)

Procedure: Conventional autografting (only when indicated)
When indicated, conventional autografting in accordance with Investigator's standard practice

Active Comparator: Mepilex® Wound Dressing

Mepilex® Wound Dressing

Conventional autografting (only when indicated)

Combination Product: Mepilex® Wound Dressing
Application of Mepilex® Wound Dressing on partial-thickness burn injury

Procedure: Conventional autografting (only when indicated)
When indicated, conventional autografting in accordance with Investigator's standard practice




Primary Outcome Measures :
  1. Requirement for conventional autografting [ Time Frame: By Week 4 post-treatment ]
    Number of index burn areas that require autografting

  2. Index burn area healing time [ Time Frame: Through study completion, Week 52 ]
    Number of days until healing


Secondary Outcome Measures :
  1. Index burn area healing time for RECELL treated compared with control [ Time Frame: Through study completion, Week 52 ]
    Index Burn Area healing time (individual endpoint for all subjects autografted or not) for ReCell treated subjects compared with control based on treating physician-investigator's assessment.

  2. Pain recovery following treatment [ Time Frame: Through study completion, Week 52 ]
    Pain at the Index Burn Area will be assessed using a 10-point scale where 10 is the worst pain imaginable or very much pain.


Other Outcome Measures:
  1. Reported need for conventional autografting [ Time Frame: Day 10 ]
    Comparison of investigator and central review results

  2. Days to healing [ Time Frame: Through study completion, Week 52 ]
    Comparison of investigator and central review results

  3. Mean pain scores at dressing changes using the Face, Legs, Activity, Cry, Consolability (FLACC) scale [ Time Frame: Up to Week 8 ]
    Mean pain scores at dressing changes assessed by the nurse performing the dressing change using the Face, Legs, Activity, Cry, Consolability (FLACC) scale.The scale is scored in a range of 0-10 with 0 representing no pain.

  4. Scar Ratings using the Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: Weeks 16, 24, and 52 ]
    Scar Ratings using the Patient and Observer Scar Assessment Scale (POSAS). Six parameters are scored in a range from 1-10 where 10 represents the worst scar imaginable.

  5. Quality of life outcomes will be captured via the age specific Burn Outcomes Questionnaire (BOQ). [ Time Frame: Weeks 1, 4, 16, 24, and 52 ]
    Outcomes (raw scores and recovery curves) from the Burn Outcomes Questionnaire (BOQ) Outcomes.

  6. Investigator treatment preference [ Time Frame: Week 52 ]
    Investigator treatment preference by asking preference of RECELL or Control treatment

  7. Health economics / medical resource utilization [ Time Frame: Through study completion, Week 52 ]
    Health economics / medical resource utilization (determined using UB-40 and/or similar hospital claim forms for billing purposes to collect cost associated with the initial hospital care and readmissions during follow-up as applicable).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients aged 1 through 16 years (inclusive) with a partial-thickness thermal burn injury.
  2. TBSA (exclusive of superficial areas) of 5 to 30% (inclusive) where ≤ 10% of the burn injury is full-thickness.
  3. In the opinion of the investigator, the patient and/or guardian must be able to:

    1. Understand the full nature and purpose of the study, including possible risks and adverse events, and
    2. Provide informed consent/assent as appropriate for study participation.
  4. The patient and/or guardian agrees to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary and comply with all compulsory study procedures and visit schedule
  5. The patient and/or guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
  6. The patient and/or guardian can read and understand instructions and give informed, voluntary, written consent.

Exclusion Criteria:

  1. Not able to read or understand English or Spanish
  2. Burns caused by chemicals, electricity or radiation
  3. Patients presenting with ONLY 3rd degree / full-thickness wounds which require immediate autografting
  4. Patients for whom use of sedation/general anesthesia is not medically appropriate.
  5. Superficial / trivial burns or burns that in the investigator's opinion appear to be healing sufficiently such that care under this protocol would be inappropriate.
  6. Conditions, e.g., previous burn injury to study area, poor nutritional status, poorly controlled diabetes mellitus (HbA1c>9%), that in the investigator's opinion may compromise subject safety or trial objectives.
  7. Current use of medications, e.g., immunosuppressive agents (excluding inhaled corticosteroids), that in the investigator's opinion may compromise subject safety or trial objectives.
  8. Inhalation injury.
  9. Active infection, cellulitis or need for immediate grafting at the planned treatment areas.
  10. Skin characteristics in areas to be photographed that could be used to identify the subject (tattoos, scars, birthmarks, etc.).
  11. Concerns for parent/guardian's ability to provide appropriate follow-up care.
  12. Subjects with a known hypersensitivity to trypsin or compound sodium lactate for irrigation solution.
  13. In post-pubescent girls, pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).
  14. Patient participating in a trial of another investigational product where this is a potential for study activities to interfere with the endpoints of this study.
  15. Immediate life-threatening condition or life expectancy less than one year.
  16. Previous randomization within this investigation.

Additional Intra-operative Eligibility Criteria:

Inclusion:

  1. At the time of initial debridement, the Index Burn Area must be no less than 160 cm2 clean partial-thickness burn injury between 2-20% BSA (inclusive) and may not cover the face, hand, foot or the perineum/genitalia (Note: a patient with these wounds may be enrolled but the Index Burn Area may not include these areas).
  2. Patient randomized (and treated) within 72 hours from the time of the burn injury.

Exclusion:

  1. Incidental finding of any pre-operative exclusion criteria.
  2. Patient requires staged procedures for treatment of partial-thickness burns.

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): NCT03626701


Contacts
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Contact: Elizabeth Kirshner 661-877-6869 ekirshner@avitamedical.com
Contact: Lisa Carothers 661-568-1311 lcarothers@avitamedical.com

Locations
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United States, Arizona
Arizona Burn Center at Maricopa Health Systems Recruiting
Phoenix, Arizona, United States, 85008
Contact: Suzanne B Osborn, RN    602-344-5141 ext 6023445141    Suzanne.Osborn@valleywisehealth.org   
Principal Investigator: Kevin Foster, MD         
United States, Florida
University of South Florida Tampa General Hospital Not yet recruiting
Tampa, Florida, United States, 33606
Contact: Kristina Rosa Bolling, MPH    813-844-8061    kristina16@health.usf.edu   
Principal Investigator: David J Smith, MD         
United States, Indiana
Riley Hospital for Chlidren Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kristin M Pothier       kpothier@IUHealth.org   
Principal Investigator: Brett Hartman, DO         
United States, Louisiana
University Medical Center New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Shana Lennard, RN    504-702-5171    shana.lennard@lcmchealth.org   
Principal Investigator: Jeffrey E Carter, MD         
United States, Missouri
Children's Mercy Kansas City Recruiting
Kansas City, Missouri, United States, 64108
Contact: Pete Muenks, MA    816-983-6670      
Principal Investigator: Pablo Aguayo, MD         
United States, North Carolina
University of North Carolina Not yet recruiting
Chapel Hill, North Carolina, United States, 27599-7600
Contact: Elisabeth Carter    919-843-7940      
Principal Investigator: Samuel W. Jones, MD         
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: D'Ann Hershel, RN    336-716-1049    dhershel@wakehealth.edu   
Contact: Brittany Christensen, MS    336-716-1049    blchrist@wakehealth.edu   
Principal Investigator: James H Holmes, IV, MD         
United States, Pennsylvania
Saint Christopher's Hospital for Children Not yet recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Linda Tate, RN    215-427-7911    linda.tate@americanacademic.com   
Principal Investigator: Paul M Glat, MD, FACS         
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: Caitlin Schaffner    843-792-7558    schaffne@musc.edu   
Principal Investigator: Steven Kahn, MD         
United States, Virginia
Evan Hayes Burn Center, Virginia Commonwealth University Not yet recruiting
Richmond, Virginia, United States, 23219
Contact: Valentina Lucas, RN         
Principal Investigator: Michael Feldman, MD         
Sponsors and Collaborators
Avita Medical
Biomedical Advanced Research and Development Authority
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Responsible Party: Avita Medical
ClinicalTrials.gov Identifier: NCT03626701    
Other Study ID Numbers: CTP006-2
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Avita Medical:
Pediatric
Burns
Partial-thickness
Additional relevant MeSH terms:
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Burns
Wounds and Injuries