[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100235998":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":39,"studyPopulation":39,"armGroups":46,"interventions":53,"overallOfficials":59,"centralContacts":64,"locations":74,"responsibleParty":168,"collaborators":39,"id":171,"slug":39,"hasResults":172,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":39,"eligibilityCriteria":176,"healthyVolunteers":172,"sex":177,"minAge":39,"maxAge":39,"enrollmentInfo":178,"targetDuration":39,"studyType":181,"phases":182,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":77,"whyStopped":39,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},{"fullName":5,"class":6},"CHU de Quebec-Universite Laval","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":18,"otherOutcomes":39},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Percentage of graft take site A vs site B (Phase A 17 patients)","Clinical assessment; Image analysis","\u003C 1 month",{"measure":14,"description":15,"timeFrame":12},"Percentage of graft take of all SASS (Phase A+B)","Clinical assessment",{"measure":17,"description":15,"timeFrame":12},"Percentage of graft take according to sites (Phase A+B)",[19,23,26,30,32,35],{"measure":20,"description":21,"timeFrame":22},"Scar evaluation site A vs site B (Phase A 17 patients)","Vancouver Scar Scales; Cutometer; Mexameter; Dermascan; Images;","3, 6, 12, 24 and 36 months",{"measure":24,"description":25,"timeFrame":22},"Scar evaluation according to sites (Phase A+B)","Cutometer; Mexameter; Dermascan; Images;",{"measure":27,"description":28,"timeFrame":29},"Incidence of adverse events site A vs site B (Phase A 17 patients)","Clinical assessment: Infection, Hematoma below the graft, corrective surgery, inclusion of cysts, granulation buds, other","24 to 36 months",{"measure":31,"description":28,"timeFrame":29},"Incidence of adverse events of all SASS (Phase A+B)",{"measure":33,"description":34,"timeFrame":22},"Quality of life survey (Phase A+B)","Survey BSHS-B ( brief version of the Burn Specific Health Scale)",{"measure":36,"description":37,"timeFrame":38},"Ratio harvested surface vs covered surface (Phase A+B)","Planimetric analysis; Clinical assessment; Images; Image analysis;","1 month",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"NA","SINGLE_GROUP","TREATMENT",{"masking":45,"maskingDescription":39,"whoMasked":39},"NONE",[47],{"label":48,"type":49,"description":50,"interventionNames":51},"Treatment (SASS)","EXPERIMENTAL","Phase A: All patients will receive both Self assembled skin substitute (SASS) and Split-thickness autograft (paired samples sites A+ B). \u002F\u002F Phase B: All patients will receive Self assembled skin subsitute (SASS)",[52],"Biological: Self assembled skin substitute (SASS)",[54],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":39},"BIOLOGICAL","Self assembled skin substitute (SASS)","All patients in Phase B will receive Self assembled skin substitute (SASS)",[48],[60],{"name":61,"affiliation":62,"role":63},"Veronique J Moulin, PhD","CHU de Quebec","PRINCIPAL_INVESTIGATOR",[65,70],{"name":61,"role":66,"phone":67,"phoneExt":68,"email":69},"CONTACT","418-525-4444","61715","veronique.moulin@fmed.ulaval.ca",{"name":71,"role":66,"phone":67,"phoneExt":72,"email":73},"Lucie Germain, PhD","61696","lucie.germain@fmed.ulaval.ca",[75,92,104,117,130,143,156],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Foothill Medcial Centre","RECRUITING","Calgary","Alberta","T2N 2T9","Canada","CA",{"type":84,"coordinates":85},"Point",[86,87],-114.08529,51.05011,{"lat":87,"lon":86},[90],{"name":91,"role":66,"phone":39,"phoneExt":39,"email":39},"Vincent Gabriel, MD",{"facility":93,"status":77,"city":94,"state":79,"zip":95,"country":81,"countryCode":82,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Mackenzie Health Science's Centre","Edmonton","T6G 2B7",{"type":84,"coordinates":97},[98,99],-113.46871,53.55014,{"lat":99,"lon":98},[102],{"name":103,"role":66,"phone":39,"phoneExt":39,"email":39},"Edward Tredget, MD",{"facility":105,"status":77,"city":106,"state":107,"zip":108,"country":81,"countryCode":82,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"BC Children's Hospital Plastic Surgery Clinic","Vancouver","British Columbia","V6H 3V4",{"type":84,"coordinates":110},[111,112],-123.11934,49.24966,{"lat":112,"lon":111},[115],{"name":116,"role":66,"phone":39,"phoneExt":39,"email":39},"Sally Hynes, MD",{"facility":118,"status":77,"city":119,"state":120,"zip":121,"country":81,"countryCode":82,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Winnipeg Health Science Center","Winnipeg","Manitoba","R3A 1R9",{"type":84,"coordinates":123},[124,125],-97.14704,49.8844,{"lat":125,"lon":124},[128],{"name":129,"role":66,"phone":39,"phoneExt":39,"email":39},"Sarvesh Logsetty, MD",{"facility":131,"status":77,"city":132,"state":133,"zip":134,"country":81,"countryCode":82,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Hospital for Sick Children (Sickkids)","Toronto","Ontario","M5G 1X8",{"type":84,"coordinates":136},[137,138],-79.39864,43.70643,{"lat":138,"lon":137},[141],{"name":142,"role":66,"phone":39,"phoneExt":39,"email":39},"Joel Fish, MD",{"facility":144,"status":77,"city":145,"state":146,"zip":147,"country":81,"countryCode":82,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Hôpital Sainte Justine","Montreal","Quebec","H3T 1C5",{"type":84,"coordinates":149},[150,151],-73.58781,45.50884,{"lat":151,"lon":150},[154],{"name":155,"role":66,"phone":39,"phoneExt":39,"email":39},"Patricia Bortoluzzi, MD",{"facility":157,"status":77,"city":158,"state":146,"zip":159,"country":81,"countryCode":82,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"CHU de Québec - Unité des grands brûlés","Québec","G1J 1Z4",{"type":84,"coordinates":161},[162,163],-71.21454,46.81228,{"lat":163,"lon":162},[166],{"name":167,"role":66,"phone":39,"phoneExt":39,"email":39},"Chanel Beaudoin-Cloutier, MD",{"type":63,"investigatorFullName":169,"investigatorTitle":170,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Veronique Moulin","Researcher","100235998",false,"NCT02350205","SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma","SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma.","Inclusion Criteria:\n\n* Deep second degree burns or third degree burns over 50% TBSA (Total body surface area) at time of recruitment or as determined by the surgeon;\n* Limited availability of donor sites for autografts;\n* Consent obtained by the participant or by the appropriate representative in case of inapt prospective participants or minors.\n\nExclusion Criteria:\n\n* Skin grafting needed only on the face, hands, feet, ears or genital area;\n* Connective tissue diseases;\n* Hypersensitivity to bovine proteins;\n* Coagulation disorders prior being burned;\n* Immunodeficiency prior being burned;\n* Uncontrolled diabetes prior being burned;\n* Permanent wound coverage before SASS grafts are ready;","ALL",{"count":179,"type":180},52,"ESTIMATED","INTERVENTIONAL",[183,184],"PHASE1","PHASE2","This clinical trial is designed to assess the safety, effectiveness and benefits of Self Assembled Skin Substitute SASS grafts as a permanent skin replacement for the treatment of full-thickness burn wounds that require permanent coverage where the availability of donor sites is limited.",[187],"Burns",[189,187,190],"Burn wounds","Skin substitute","2025-07-22",{"date":193,"type":194},"2025-07-25","ACTUAL",{"date":196,"type":194},"2015-12",{"date":198,"type":180},"2029-01",{"name":5,"class":6},7]