CONTINUED ACCESS PROTOCOL: Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries

NCT02994654 | Completed Results

• 1 other identifier: CTP001-7
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 6

Brief Summary

The overall purpose of this is study to provide continued access to the ReCell device following completion of protocol CTP001-6, and allow for collection of supplementary clinical outcome data for the ReCell device when used as an adjunct to meshed grafts in subjects with acute thermal burn injuries who require skin grafting for closure of burn injuries.

Conditions

Burns

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)

  Complete wound closure is defined as skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for ReCell-treated areas as compared to control areas.

  Prior to or at 8 weeks

• Relative Reduction in Donor Skin Area Requirement

  For this second co-primary endpoint, it is hypothesized that the expansion ratio associated with the RECELL treatment area will be superior to that of the control, i.e. less donor skin will be required for RECELL-treated areas compared with the control areas.

  Prior to or at 8 weeks

Study Arms (2)

ReCell

EXPERIMENTAL

All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B

Device: ReCell

Control

EXPERIMENTAL

All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Control, which is the Investigator's pre-determined graft plan will be randomly allocated to either Area A or Area B

Device: ReCell

Interventions

ReCell DEVICE

The ReCell-assigned treatment area will be treated as described in the product's Instructions for Use. In summary, 1ml of fluid physically covers a treatment area of 80 cm2. Each milliliter of fluid contains cells harvested from a square centimeter of thin split-thickness skin sample. The reagents and components of the ReCell kit are used, in a scalable fashion, to facilitate disaggregation of cells from skin samples into filtered cell suspension. Areas to be harvested for skin samples are to be clean and show no evidence of surrounding cellulitis or infection. Treatment area sizes and cell suspension volumes are to be recorded.

Control; ReCell

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject requires skin grafting as a result of an acute thermal burn injury (i.e. injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or water).
• The area of total burn injury is 5-50% TBSA inclusive.
• Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous), excluding hand/face and joints.
• The subject is at least 5 years of age.
• The subject (or family, for those under 18 years of age) is willing and able to complete all follow-up evaluations required by the study protocol.
• The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary.
• The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
• The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent.

You may not qualify if:

• The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances.
• The subject is unable to follow the protocol.
• The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
• The subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
• Life expectancy is less than 1year.

Sponsors & Collaborators

• Avita Medical: lead

Study Sites (6)

Arizona Burn Center at Maricopa Integrated Health Systems

Phoenix, Arizona, 85008, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38103-3409, United States

Location

U.S.Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234-7767, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: VP Clinical Research
• Organization: AVITA Medical

USClinicalTrials@avitamedical.com

661-367-9170

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 16, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: September 1, 2018
• Last Updated: July 30, 2024
• Results First Posted: May 4, 2021

Record last verified: 2024-07

Locations

US (6)