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

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)

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.

Study Overview

• Status: Terminated
• Conditions: Burns
• Intervention / Treatment: Procedure: Conventional autografting (only when indicated); Device: RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device; Combination product: Mepilex® Ag Wound Dressing

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RECELL® Autologous Cell Harvesting Device; RECELL + Telfa™ Clear and Xeroform™ dressings Conventional autografting (only when indicated)	Procedure: Conventional autografting (only when indicated); When indicated, conventional autografting in accordance with Investigator's standard practice; Device: RES (Regenerative Epidermal Suspension) prepared using the 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.
Active Comparator: Mepilex® Ag Wound Dressing; Mepilex® Ag Wound Dressing Conventional autografting (only when indicated)	Procedure: Conventional autografting (only when indicated); When indicated, conventional autografting in accordance with Investigator's standard practice; Combination product: Mepilex® Ag Wound Dressing; Application of Mepilex® Ag Wound Dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Index Burns With Day 10 Healing	Day 10 healing will be evaluated by an observer blinded to treatment allocation with confirmation at Day 28	10 Days post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Day 21 Healing of the Index Burn	Incidence of Day 21 healing of the Index Burn confirmed on Day 28	Day 21, confirmed on Day 28
Incidence of Conventional Autografting to Achieve Healing of the Index Burn	Incidence of conventional autografting to achieve healing of the Index Burn	Through Day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute area (cm2) of Index Burn requiring autografting	Absolute area (cm2) of Index Burn requiring autografting	Through Day 28
Index Burn pain scores at dressing changes using the Face, Legs, Activity, Cry, Consolability (FLACC) scale	Index Burn pain scores at dressing changes assessed by the Health Care Provider	Up to Week 8
Subject reported Index Burn pain scores at dressing changes.	Subject reported Index Burn pain scores at dressing changes.	Up to Week 8
Percent epithelialization of the Index Burn per digital planimetry	Percent epithelialization of the Index Burn per digital planimetry	Up to Week 8
Index Burn Patient and Observer Scar Assessment Scale (POSAS) scar ratings	Index Burn Patient and Observer Scar Assessment Scale (POSAS) scar ratings	Weeks 16, 24, 36 and 52
BOQ Outcomes (raw scores and recovery curves for all domains), with baseline at Day 10	Outcomes (raw scores and recovery curves) from the Burn Outcomes Questionnaire (BOQ) Outcomes.	Day 10 and 28, Weeks 16, 24, 36 and 52
Investigator treatment preference	Investigator treatment preference by asking preference of RECELL or Control treatment	Week 52
Health economics / medical resource utilization	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).	Through Week 52
Index Burn Itch Man Scale ratings	Index Burn Itch Man Scale ratings	Up to Week 8

Collaborators and Investigators

• Sponsor: Avita Medical
• Collaborators: Biomedical Advanced Research and Development Authority

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Actual): June 23, 2021
• Study Completion (Actual): June 3, 2022

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Pediatric; Burns; Partial-thickness
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: CTP006-2; RESTORE KIDS (Other Identifier: AVITA Medical)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes