[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100285362":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":23,"locations":24,"responsibleParty":88,"collaborators":23,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":23,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":97,"minAge":98,"maxAge":23,"enrollmentInfo":99,"targetDuration":23,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":23,"overallStatus":108,"whyStopped":23,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Avita Medical","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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",[13],"Device: ReCell",{"label":15,"type":10,"description":16,"interventionNames":17},"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",[13],[19],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"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.\n\nThe 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.",[15,9],null,[25,38,48,58,68,78],{"facility":26,"status":23,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":23},"Arizona Burn Center at Maricopa Integrated Health Systems","Phoenix","Arizona","85008","United States","US",{"type":33,"coordinates":34},"Point",[35,36],-112.07404,33.44838,{"lat":36,"lon":35},{"facility":39,"status":23,"city":40,"state":41,"zip":42,"country":30,"countryCode":31,"cosmosGeoPoint":43,"geoPoint":47,"contacts":23},"MedStar Washington Hospital Center","Washington D.C.","District of Columbia","20010",{"type":33,"coordinates":44},[45,46],-77.03637,38.89511,{"lat":46,"lon":45},{"facility":49,"status":23,"city":50,"state":51,"zip":52,"country":30,"countryCode":31,"cosmosGeoPoint":53,"geoPoint":57,"contacts":23},"Tampa General Hospital","Tampa","Florida","33606",{"type":33,"coordinates":54},[55,56],-82.45843,27.94752,{"lat":56,"lon":55},{"facility":59,"status":23,"city":60,"state":61,"zip":62,"country":30,"countryCode":31,"cosmosGeoPoint":63,"geoPoint":67,"contacts":23},"Wake Forest Baptist Medical Center","Winston-Salem","North Carolina","27157",{"type":33,"coordinates":64},[65,66],-80.24422,36.09986,{"lat":66,"lon":65},{"facility":69,"status":23,"city":70,"state":71,"zip":72,"country":30,"countryCode":31,"cosmosGeoPoint":73,"geoPoint":77,"contacts":23},"University of Tennessee Health Science Center","Memphis","Tennessee","38103-3409",{"type":33,"coordinates":74},[75,76],-90.04898,35.14953,{"lat":76,"lon":75},{"facility":79,"status":23,"city":80,"state":81,"zip":82,"country":30,"countryCode":31,"cosmosGeoPoint":83,"geoPoint":87,"contacts":23},"U.S.Army Institute of Surgical Research","Fort Sam Houston","Texas","78234-7767",{"type":33,"coordinates":84},[85,86],-98.4417,29.45303,{"lat":86,"lon":85},{"type":89,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100285362","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-100285362",true,"NCT02994654","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","Inclusion Criteria:\n\n1. 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\u002Fflames, excessive heat, hot steam or water).\n2. The area of total burn injury is 5-50% TBSA inclusive.\n3. Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous), excluding hand\u002Fface and joints.\n4. The subject is at least 5 years of age.\n5. 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.\n6. The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary.\n7. The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.\n8. The subject and\u002For guardian are able to read and understand instructions and give informed, voluntary, written consent.\n\nExclusion Criteria:\n\n1. The subject's burn injuries were caused by chemicals, electricity, and\u002For radioactive substances.\n2. The subject is unable to follow the protocol.\n3. The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.\n4. The subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.\n5. Life expectancy is less than 1year.",false,"ALL","5 Years",{"count":100,"type":101},12,"ACTUAL","INTERVENTIONAL",[104],"NA","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.",[107],"Burns","COMPLETED","2024-07-09",{"date":111,"type":101},"2024-07-30",{"date":113,"type":23},"2016-10",{"date":115,"type":101},"2018-09",{"name":5,"class":6},6]