Clinical trial NCT03626701: RES® Prepared With RECELL® Compared to Standard of Care Dressings of Partial-thickness Burns in Ages 1-16 Years
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Burns
Keywords: Pediatric
Burns
Partial-thickness
Lead sponsor: Avita Medical
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2018-08-13
Enrollment: 19
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 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.

Primary outcomes:
measure: Incidence of Index Burns With Day 10 Healing
timeFrame: 10 Days post-treatment
Secondary outcomes:
measure: Incidence of Day 21 Healing of the Index Burn
timeFrame: Day 21, confirmed on Day 28
measure: Incidence of Conventional Autografting to Achieve Healing of the Index Burn
timeFrame: Through Day 28
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Burn Center / Valleywise Health
state: Arizona
city: Tampa
country: United States
facility: University of South Florida Tampa General Hospital
state: Florida
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Saint Christopher's Hospital for Children
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Richmond
country: United States
facility: Evan Hayes Burn Center, Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: University of Washington Regional Burn Center at Harborview Medical Center
state: Washington
Study officials:
References: