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

• ClinicalTrials.gov Identifier: NCT02994654
• Recruitment Status: Completed
• First Posted: December 16, 2016
• Results First Posted: May 4, 2021
• Last Update Posted: May 4, 2021
• Sponsor: Avita Medical
• Information provided by (Responsible Party): Avita Medical

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Burns	Device: ReCell	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: October 2016
• Actual Primary Completion Date: December 2017
• Actual Study Completion Date: September 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: ReCell; 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; 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.
Experimental: Control; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority) [ Time Frame: Prior to or at 8 weeks ]
   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.
2. Relative Reduction in Donor Skin Area Requirement [ Time Frame: Prior to or at 8 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 5 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. 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).
2. The area of total burn injury is 5-50% TBSA inclusive.
3. Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous), excluding hand/face and joints.
4. The subject is at least 5 years of age.
5. 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.
6. The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary.
7. The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
8. The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent.

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, Arizona

Arizona Burn Center at Maricopa Integrated Health Systems

Phoenix, Arizona, United States, 85008

United States, District of Columbia

MedStar Washington Hospital Center

Washington, District of Columbia, United States, 20010

United States, Florida

Tampa General Hospital

Tampa, Florida, United States, 33606

United States, North Carolina

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

United States, Tennessee

University of Tennessee Health Science Center

Memphis, Tennessee, United States, 38103-3409

United States, Texas

U.S.Army Institute of Surgical Research

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

Sponsors and Collaborators

Avita Medical

  Study Documents (Full-Text)

Documents provided by Avita Medical:

Study Protocol and Informed Consent Form  [PDF] August 25, 2016

Statistical Analysis Plan  [PDF] May 7, 2018

More Information

• Responsible Party: Avita Medical
• ClinicalTrials.gov Identifier: NCT02994654
• Other Study ID Numbers: CTP001-7
• First Posted: December 16, 2016
• Results First Posted: May 4, 2021
• Last Update Posted: May 4, 2021
• Last Verified: April 2021

Additional relevant MeSH terms:

Burns; Wounds and Injuries