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

Not Applicable

Terminated

• Conditions: Burns
• Interventions: Device: RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device; Combination Product: Mepilex® Ag Wound Dressing; Procedure: Conventional autografting (only when indicated)

• Registration Number: NCT03626701
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-20
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-13
• Study Start: 2020-03-03
• Primary Completion: 2021-06-23
• Study Completion: 2022-06-03
• Results First Submitted: 2023-05-31
• Results First Submitted QC: 2023-05-31
• Results First Posted: 2023-06-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RECELL® Autologous Cell Harvesting Device	RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device	RECELL + Telfa™ Clear and Xeroform™ dressings Conventional autografting (only when indicated)
RECELL® Autologous Cell Harvesting Device	Conventional autografting (only when indicated)	RECELL + Telfa™ Clear and Xeroform™ dressings Conventional autografting (only when indicated)
Mepilex® Ag Wound Dressing	Mepilex® Ag Wound Dressing	Mepilex® Ag Wound Dressing Conventional autografting (only when indicated)
Mepilex® Ag Wound Dressing	Conventional autografting (only when indicated)	Mepilex® Ag Wound Dressing Conventional autografting (only when indicated)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of Day 21 Healing of the Index Burn	Day 21, confirmed on Day 28	Incidence of Day 21 healing of the Index Burn confirmed on Day 28
Incidence of Conventional Autografting to Achieve Healing of the Index Burn	Through Day 28	Incidence of conventional autografting to achieve healing of the Index Burn

Trial Locations

Locations (9)

Saint Christopher's Hospital for Children; 🇺🇸 Philadelphia, Pennsylvania, United States

University Medical Center New Orleans; 🇺🇸 New Orleans, Louisiana, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Evan Hayes Burn Center, Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

University of Washington Regional Burn Center at Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

Arizona Burn Center / Valleywise Health; 🇺🇸 Phoenix, Arizona, United States

University of South Florida Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States