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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Burns

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients aged 1 through 16 years (inclusive) with a partial-thickness thermal burn injury. The patient has a thermal burn injury that is: ≤ 30% TBSA (exclusive of superficial areas) and ≤ 10% of the burn injury TBSA is a full-thickness burn. The Index Burn must be a clean partial-thickness burn injury > or = to 160 cm2 and between 2-20% BSA (inclusive). 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). The patient and/or guardian agrees to comply with all compulsory study procedures and visit schedule. 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. The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study. In the opinion of the investigator, the patient and/or parent/guardian must be able to: Understand the full nature and purpose of the study, including possible risks and adverse events, Understand instruction, and Provide voluntary informed written consent/assent as appropriate for study participation. Exclusion Criteria: Not able to understand English or Spanish. Burns caused by chemicals, electricity or radiation. Patients presenting with only 3rd-degree/full-thickness wounds which require immediate autografting. Burn injury has had prior treatment for definitive closure. Patients for whom use of sedation/general anesthesia is not medically appropriate. 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. Patient requires immediate or staged surgical procedures for closure of their partial-thickness burns. 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. Current use of medications, e.g., immunosuppressive agents (excluding inhaled corticosteroids), that in the investigator's opinion may compromise subject safety or trial objectives. Inhalation injury. Active infection, cellulitis or need for immediate grafting at the planned treatment areas. Concerns for parent/guardian's ability to provide appropriate follow-up care. Subjects with a known hypersensitivity to trypsin or compound sodium lactate for irrigation solution. Subjects with a known sensitivity to silver. In post-pubescent girls, pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements). Immediate life-threatening condition or life expectancy less than one year. Previous randomization within this investigation. Post-Randomization Inclusion Criteria (prior to treatment): Patient randomized (and will be treated) within 72 hours from the time of the burn injury. 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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, Burns, Partial-thickness