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

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ClinicalTrials.gov Identifier: NCT03626701
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : August 7, 2020
Sponsor:
Collaborator:
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
Avita Medical

Tracking Information
First Submitted Date  ICMJE July 20, 2018
First Posted Date  ICMJE August 13, 2018
Last Update Posted Date August 7, 2020
Actual Study Start Date  ICMJE March 3, 2020
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2020)
  • Incidence of Index Burns with Day 10 healing [ Time Frame: Day 10 ]
    Day 10 healing is defined as the presence of ≥95% skin epithelialization without drainage or dressing required for healing.
  • Index Burn Healing Confirmation [ Time Frame: Day 28 ]
    Healing is defined as the presence of ≥95% skin epithelialization without drainage or dressing required for healing. The Day 28 visit confirms the original incidence of healing recorded at Day 10
Original Primary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
  • Requirement for conventional autografting [ Time Frame: By Week 4 post-treatment ]
    Number of index burn areas that require autografting
  • Index burn area healing time [ Time Frame: Through study completion, Week 52 ]
    Number of days until healing
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2020)
  • Incidence of healing (≥95% skin epithelialization) of the Index Burn on or before Day 21, confirmed on Day 28 [ Time Frame: Day 21, confirmed on Day 28 ]
    Incidence of healing (≥95% skin epithelialization) of the Index Burn
  • Percent area of Index Burn requiring autografting [ Time Frame: Through Day 28 ]
    Percent area of Index Burn requiring autografting
  • Incidence of conventional autografting to achieve healing [ Time Frame: Through Day 28 ]
    Incidence of conventional autografting to achieve healing.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures
 (submitted: August 6, 2020)
  • Absolute area (cm2) of Index Burn requiring autografting [ Time Frame: Through Day 28 ]
    Absolute area (cm2) of Index Burn requiring autografting
  • Index Burn pain scores at dressing changes using the Face, Legs, Activity, Cry, Consolability (FLACC) scale [ Time Frame: Up to Week 8 ]
    Index Burn pain scores at dressing changes assessed by the HCP
  • Subject reported Index Burn pain scores at dressing changes. [ Time Frame: Up to Week 8 ]
    Subject reported Index Burn pain scores at dressing changes.
  • Percent epithelialization of the Index Burn per digital planimetry [ Time Frame: Up to Week 8 ]
    Percent epithelialization of the Index Burn per digital planimetry
  • Index Burn Patient and Observer Scar Assessment Scale (POSAS) scar ratings [ Time Frame: Weeks 16, 24, 36 and 52 ]
    Index Burn Patient and Observer Scar Assessment Scale (POSAS) scar ratings
  • BOQ Outcomes (raw scores and recovery curves for all domains), with baseline at Day 10 [ Time Frame: Day 10 and 28, Weeks 16, 24, 36 and 52 ]
    Outcomes (raw scores and recovery curves) from the Burn Outcomes Questionnaire (BOQ) Outcomes.
  • Investigator treatment preference [ Time Frame: Week 52 ]
    Investigator treatment preference by asking preference of RECELL or Control treatment
  • Health economics / medical resource utilization [ Time Frame: Through Week 52 ]
    Health economics / medical resource utilization (determined using UB-04 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).
  • Index Burn Itch Man Scale ratings [ Time Frame: Up to Week 8 ]
    Index Burn Itch Man Scale ratings
Original Other Pre-specified Outcome Measures
 (submitted: August 9, 2018)
  • Reported need for conventional autografting [ Time Frame: Day 10 ]
    Comparison of investigator and central review results
  • Days to healing [ Time Frame: Through study completion, Week 52 ]
    Comparison of investigator and central review results
  • 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.
  • 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.
  • 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.
  • Investigator treatment preference [ Time Frame: Week 52 ]
    Investigator treatment preference by asking preference of RECELL or Control treatment
  • 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).
 
Descriptive Information
Brief Title  ICMJE RES® Prepared With RECELL® Compared to Standard of Care Dressings of Partial-thickness Burns in Ages 1-16 Years
Official Title  ICMJE 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)
Brief Summary A prospective, parallel-arm, randomized (1:1) multicenter trial to demonstrate that RECELL treatment of partial-thickness burn injuries, can safely and effectively increase the incidence of Day 10 healing compared with a standardized wound dressing.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Burns
Intervention  ICMJE
  • 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)
  • Combination Product: Mepilex® Ag Wound Dressing
    Application of Mepilex® Ag Wound Dressing on partial-thickness burn injury
  • Procedure: Conventional autografting (only when indicated)
    When indicated, conventional autografting in accordance with Investigator's standard practice
Study Arms  ICMJE
  • Experimental: RECELL® Autologous Cell Harvesting Device

    RECELL + Telfa™ Clear and Xeroform™ dressings

    Conventional autografting (only when indicated)

    Interventions:
    • Device: RECELL® Autologous Cell Harvesting Device
    • Procedure: Conventional autografting (only when indicated)
  • Active Comparator: Mepilex® Ag Wound Dressing

    Mepilex® Ag Wound Dressing

    Conventional autografting (only when indicated)

    Interventions:
    • Combination Product: Mepilex® Ag Wound Dressing
    • Procedure: Conventional autografting (only when indicated)
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 6, 2020)
160
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2018)
210
Estimated Study Completion Date  ICMJE December 1, 2023
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. The Index Burn must be no less than a 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 wounds in these areas may be enrolled but the Index Burn may not include these areas).
  4. The patient and/or guardian agrees to comply with all compulsory study procedures and visit schedule
  5. The patient and/or parent/guardian agrees to abstain from any other treatment for closure of the Index Burn for the duration of the study, unless medically necessary.
  6. The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
  7. 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.
    3. Provide voluntary informed written consent/assent as appropriate for study participation

Exclusion Criteria:

  1. Not able to 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. Burn injury has had prior treatment for definitive closure.
  5. Patients for whom use of sedation/general anesthesia is not medically appropriate.
  6. 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.
  7. Patient requires immediate or staged surgical procedures for closure of their partial-thickness burns.
  8. 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.
  9. Current use of medications, e.g., immunosuppressive agents (excluding inhaled corticosteroids), that in the investigator's opinion may compromise subject safety or trial objectives.
  10. Inhalation injury.
  11. Active infection, cellulitis or need for immediate grafting at the planned treatment areas.
  12. Concerns for parent/guardian's ability to provide appropriate follow-up care.
  13. Subjects with a known hypersensitivity to trypsin or compound sodium lactate for irrigation solution.
  14. Subjects with a known sensitivity to silver.
  15. In post-pubescent girls, pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).
  16. Immediate life-threatening condition or life expectancy less than one year.
  17. Previous randomization within this investigation.

Post-Randomization Inclusion Criteria (prior to treatment):

  1. Patient randomized (and will be treated) within 72 hours from the time of the burn injury.
  2. Patient continues to meet all pre-randomization inclusion criteria.

Post-Randomization Exclusion Criteria (prior to treatment):

1. Incidental finding of any pre-randomization exclusion criteria.

Consented subjects who do not meet the post-randomization eligibility criteria and did not receive study treatment will be followed through the Day 28 visit and then withdrawn from the study. The criteria for which exclusion was based will be documented.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elizabeth Kirshner 661-877-6869 ekirshner@avitamedical.com
Contact: Lisa Carothers 661-568-1311 lcarothers@avitamedical.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03626701
Other Study ID Numbers  ICMJE CTP006-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avita Medical
Study Sponsor  ICMJE Avita Medical
Collaborators  ICMJE Biomedical Advanced Research and Development Authority
Investigators  ICMJE Not Provided
PRS Account Avita Medical
Verification Date August 2020

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