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

NCT03626701 | Terminated Results DMC FDA Device

• 2 other identifiers: CTP006-2RESTORE KIDS
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 9

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.

Conditions

Burns

Keywords

Pediatric; Burns; Partial-thickness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of Day 21 Healing of the Index Burn

  Day 21, confirmed on Day 28

• Incidence of Conventional Autografting to Achieve Healing of the Index Burn

  Through Day 28

Study Arms (2)

RECELL® Autologous Cell Harvesting Device

EXPERIMENTAL

RECELL + Telfa™ Clear and Xeroform™ dressings Conventional autografting (only when indicated)

Device: RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device; Procedure: Conventional autografting (only when indicated)

Mepilex® Ag Wound Dressing

ACTIVE COMPARATOR

Mepilex® Ag Wound Dressing Conventional autografting (only when indicated)

Combination Product: Mepilex® Ag Wound Dressing; Procedure: Conventional autografting (only when indicated)

Interventions

RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device DEVICE

Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings.

RECELL® Autologous Cell Harvesting Device

Mepilex® Ag Wound Dressing COMBINATION_PRODUCT

Application of Mepilex® Ag Wound Dressing

Mepilex® Ag Wound Dressing

Conventional autografting (only when indicated) PROCEDURE

When indicated, conventional autografting in accordance with Investigator's standard practice

Mepilex® Ag Wound Dressing; RECELL® Autologous Cell Harvesting Device

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Avita Medical: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (9)

Arizona Burn Center / Valleywise Health

Phoenix, Arizona, 85008, United States

Location

University of South Florida Tampa General Hospital

Tampa, Florida, 33606, United States

Location

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599-7600, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Evan Hayes Burn Center, Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

University of Washington Regional Burn Center at Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Elizabeth Kirshner
• Organization: AVITA Medical

ekirshner@avitamedical.com

661-877-6869

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 1. Blinded Evaluator/Observer - local burn specialist 2. Independent Reviewer
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 13, 2018
• Study Start: March 3, 2020
• Primary Completion: June 23, 2021
• Study Completion: June 3, 2022
• Last Updated: July 30, 2024
• Results First Posted: June 26, 2023

Record last verified: 2024-07

Locations

US (9)