A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness 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-patient controlled study to compare the clinical performance of the ReCell Device with that of Split-thickness Meshed Skin Grafts for the treatment of second degree burns. The hypothesis to be supported are: 1) non-inferiority with the primary efficacy endpoint defined as recipient site wound closure at week 4 follow-up visit of the ReCell-treated area as compared to that of the STMSG-treated area, and 2)superiority in the healing of the ReCell donor site as compared to the STMSG donor site at week 1.

Official Title
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A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries

Conditions
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Burns

Intervention / Treatment
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* Device: ReCell and Split-thickness skin graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject requires primary skin grafting as a result of an acute thermal burn injury The area of the burn injury is at least 200cm2 (1% TBSA in adults) if a contiguous wound, or at least 100cm2 for each of 2 noon-contiguous wounds The area of total burn injury is 1-20% TBSA The burn injured area can be divided into two treatment areas ( control and treatment) with 100-320cm2 area for each treatment type The study treatment area is a second degree burn injury The subject is between 18-65 years of age The subject is willing 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 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 The subject is able and willing to follow the protocol requirements Exclusion Criteria: The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances The total subject burn injury is less than 1% or more than 20% TBSA The subject has a microbiologically proven pre-existing local or systemic bacterial infection The subject has been receiving a systemic antibiotic for more than 48 hours prior to grafting The subject is known to have a pre-existing condition that may interfere with wound healing ( e.g. malignancy, diabetes, or autoimmune disease) The subject is unable to follow the protocol The subject is taking medication known to have an effect on wound healing or skin pigmentation ( e.g. systemic corticosteroids, retinoids, etc) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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<br>All participants will receive both ReCell and split-thickness skin graft | Device: ReCell and Split-thickness skin graft<br>* The surgeon will be required to select two similar non-contiguous injury areas with both areas being at least 100cm2 and second degree depth/severity. One area will be treated using ReCell and the second using Split-thickness Skin Graft.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority) | Recipient site wound closure for both ReCell and STMSG will be defined as the presence of >=95% epithelialization with contiguous layer of viable epithelium without the need for secondary surgical intervention. Factors considered during the assessment included color, presence of granulation tissue, and whether or not the entire wound is covered with a contiguous layer of viable epithelium. Using this definition, some small degree of punctate blistering was acceptable as long as the wound was >=95% epithelialized. | 4 weeks | 
| Incidence of RECELL Donor Site Healing Compared to Control at 1 Week (Superiority) | Donor site healing will be considered as complete (100%) wound closure if the following criteria were met: an ability to separate the dressing from the wound bed with visible presence over the entirety of the wound of dry, opalescent-pink external surface representing the newly formed outer cornfield layer of the epidermis. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Epithelialization at Each Visit Through Week 16 | The percent epithelialization of the RECELL and Control treated sites will be assessed using standardized planimetry/tracing procedures. The tracings were uploaded to a Central Reading Facility for calculation of percent epithelialization using a computerized measurement technique. | Each visit through Week 16 | 
| Wound Closure at Week 2 (Based on Investigators Assessment) | The proportion of recipient sites achieving wound closure at Week 2 was evaluated using the Investigators assessment of wound healing. | Week 2 | 
| Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment) | Subject assessment of pain at the RECELL and Control recipient sites was performed at all study follow-up visits up to Week 16. Subjects also assessed the satisfaction with the appearance of the treatment sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires. Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional | Pain (Weeks 1-16) and Appearance (Weeks 16-52) | 
| Mean Pain and Appearance Scores at Donor Sites (Subject Assessment) | Subject assessment of pain at the RECELL and Control donor sites was performed at all study follow-up visits up to Week 16. Subjects also assessed the satisfaction with the appearance of the donor sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires. Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional. | Pain (Weeks 1-16) and Appearance (Weeks 16-52) | 

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