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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03626701
Recruitment Status : Terminated (In June 2021, the US FDA approved expanded use of the RECELL System for treatment of acute full-thickness thermal burns in patients 1-month of age and older (removing the prior limitation of use in patients younger than 18 years of age).)
First Posted : August 13, 2018
Last Update Posted : November 25, 2022
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 RECELL treatment of partial-thickness burn injuries, can safely and effectively increase the incidence of Day 10 healing compared with a standardized wound dressing.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 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
Actual Primary Completion Date : June 23, 2021
Actual Study Completion Date : June 3, 2022

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® Ag Wound Dressing

Mepilex® Ag Wound Dressing

Conventional autografting (only when indicated)

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




Primary Outcome Measures :
  1. Incidence of Index Burns with Day 10 healing [ Time Frame: Day 10 ]
    Day 10 healing will be evaluated by an observer blinded to treatment allocation with confirmation at Day 28

  2. Index Burn Healing Confirmation [ Time Frame: Day 28 ]
    The Day 28 visit confirms the original incidence of healing recorded at Day 10


Secondary Outcome Measures :
  1. Incidence of Day 21 healing of the Index Burn [ Time Frame: Day 21, confirmed on Day 28 ]
    Incidence of Day 21 healing of the Index Burn confirmed on Day 28

  2. Percent area of Index Burn requiring autografting [ Time Frame: Through Day 28 ]
    Percent area of Index Burn requiring autografting

  3. Incidence of conventional autografting to achieve healing of the Index Burn [ Time Frame: Through Day 28 ]
    Incidence of conventional autografting to achieve healing of the Index Burn


Other Outcome Measures:
  1. Absolute area (cm2) of Index Burn requiring autografting [ Time Frame: Through Day 28 ]
    Absolute area (cm2) of Index Burn requiring autografting

  2. 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 Health Care Provider

  3. Subject reported Index Burn pain scores at dressing changes. [ Time Frame: Up to Week 8 ]
    Subject reported Index Burn pain scores at dressing changes.

  4. Percent epithelialization of the Index Burn per digital planimetry [ Time Frame: Up to Week 8 ]
    Percent epithelialization of the Index Burn per digital planimetry

  5. 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

  6. 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.

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

  8. Health economics / medical resource utilization [ Time Frame: Through Week 52 ]
    Health economics / medical resource utilization (determined using UB-04 CMS-1500 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).

  9. Index Burn Itch Man Scale ratings [ Time Frame: Up to Week 8 ]
    Index Burn Itch Man Scale ratings



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. The patient has a thermal burn injury that is:

    1. ≤ 30% TBSA (exclusive of superficial areas) and
    2. ≤ 10% of the burn injury TBSA is a full-thickness burn.
  3. The Index Burn must be a clean partial-thickness burn injury > or = to 160 cm2 and between 2-20% BSA (inclusive).
  4. The Index Burn 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 Area may not include these areas).
  5. The patient and/or guardian agrees to comply with all compulsory study procedures and visit schedule.
  6. 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.
  7. The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
  8. In the opinion of the investigator, the patient and/or parent/guardian must be able to:

    1. Understand the full nature and purpose of the study, including possible risks and adverse events,
    2. Understand instruction, and
    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.


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


Locations
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United States, Arizona
Arizona Burn Center / Valleywise Health
Phoenix, Arizona, United States, 85008
United States, Florida
University of South Florida Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Louisiana
University Medical Center New Orleans
New Orleans, Louisiana, United States, 70112
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599-7600
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Virginia
Evan Hayes Burn Center, Virginia Commonwealth University
Richmond, Virginia, United States, 23219
United States, Washington
University of Washington Regional Burn Center at Harborview Medical Center
Seattle, Washington, United States, 98104
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: November 25, 2022
Last Verified: November 2022

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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