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

Burns Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03626701
• Other study ID #: CTP006-2
• Secondary ID: RESTORE KIDS
• Status: Terminated
• Phase: N/A
• Start date: March 3, 2020
• Est. completion date: June 3, 2022

Study information

• Verified date: May 2023
• Source: Avita Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: June 3, 2022
• Est. primary completion date: June 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

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.

Combination Product:
• Mepilex® Ag Wound Dressing
Application of Mepilex® Ag Wound Dressing

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

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University Medical Center New Orleans	New Orleans	Louisiana
United States	Saint Christopher's Hospital for Children	Philadelphia	Pennsylvania
United States	Arizona Burn Center / Valleywise Health	Phoenix	Arizona
United States	Evan Hayes Burn Center, Virginia Commonwealth University	Richmond	Virginia
United States	University of Washington Regional Burn Center at Harborview Medical Center	Seattle	Washington
United States	University of South Florida Tampa General Hospital	Tampa	Florida
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Avita Medical	Biomedical Advanced Research and Development Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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