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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Burns

Intervention / Treatment
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* Device: ReCell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 5 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReCell<br>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<br>* 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.<br>|
| Experimental: Control<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |