ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries

Study Overview
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Brief Summary
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This is a randomized, within-subject controlled study to compare the clinical performance of the ReCell device when used as an adjunct to meshed skin graft in subjects requiring skin grafts for closure of burn injuries. Co-primary effectiveness endpoints include: (1) confirmed treatment area closure (i.e., healing) prior to or at 8 weeks as assessed by a blinded evaluator, and (2) a comparison of the actual expansion ratio, computed as the ratio of measured treated area to the measured donor site area, achieved for the ReCell-treated and control treatment areas. Safety will be evaluated in terms of long-term durability, scar outcomes and treatment-related adverse events.

Official Title
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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 Treatment
* Procedure: Skin Graft


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 followup 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 1 year.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Participants (within patient 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. Investigational treatment will be randomly allocated to either Area A or Area B | Device: ReCell Treatment<br> <br> Procedure: Skin Graft<br> <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 | 
| Actual Expansion Ratios (Treatment Area to Donor Site Area, Inclusive of Donor Skin Needed for Secondary Treatments) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observer Overall Patient and Observer Scar Assessment Scale ( POSAS) Opinion Score | The observer component of the Patient and Observer Scar Assessment Scale (POSAS) questionnaire required the blinded evaluator to provide an overall opinion of the treatment area compared to normal skin, scored from 1 (normal skin) to 10 (worst imaginable scar). | At 24 Week | 
| Patient's Satisfaction/Treatment Preference |  | At 24 Week | 
| Patient Overall Patient and Observer Scar Assessment Scale (POSAS) Opinion Score | The patient component of the Patient Overall Patient and Observer Scar Assessment Scale (POSAS) questionnaire required the patient to provide an overall opinion of the treatment area compared to normal skin, scored from 1 (normal skin) to 10 (worst imaginable scar). T | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Second Degree Burn Injuries