Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2026-02-24 @ 5:05 AM
Study NCT ID:
NCT02350205
Status:
RECRUITING
Last Update Posted:
2025-07-25
First Post:
2015-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2015-01-15', 'studyFirstSubmitQcDate': '2015-01-26', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of graft take site A vs site B (Phase A 17 patients)', 'timeFrame': '< 1 month', 'description': 'Clinical assessment; Image analysis'}, {'measure': 'Percentage of graft take of all SASS (Phase A+B)', 'timeFrame': '< 1 month', 'description': 'Clinical assessment'}, {'measure': 'Percentage of graft take according to sites (Phase A+B)', 'timeFrame': '< 1 month', 'description': 'Clinical assessment'}], 'secondaryOutcomes': [{'measure': 'Scar evaluation site A vs site B (Phase A 17 patients)', 'timeFrame': '3, 6, 12, 24 and 36 months', 'description': 'Vancouver Scar Scales; Cutometer; Mexameter; Dermascan; Images;'}, {'measure': 'Scar evaluation according to sites (Phase A+B)', 'timeFrame': '3, 6, 12, 24 and 36 months', 'description': 'Cutometer; Mexameter; Dermascan; Images;'}, {'measure': 'Incidence of adverse events site A vs site B (Phase A 17 patients)', 'timeFrame': '24 to 36 months', 'description': 'Clinical assessment: Infection, Hematoma below the graft, corrective surgery, inclusion of cysts, granulation buds, other'}, {'measure': 'Incidence of adverse events of all SASS (Phase A+B)', 'timeFrame': '24 to 36 months', 'description': 'Clinical assessment: Infection, Hematoma below the graft, corrective surgery, inclusion of cysts, granulation buds, other'}, {'measure': 'Quality of life survey (Phase A+B)', 'timeFrame': '3, 6, 12, 24 and 36 months', 'description': 'Survey BSHS-B ( brief version of the Burn Specific Health Scale)'}, {'measure': 'Ratio harvested surface vs covered surface (Phase A+B)', 'timeFrame': '1 month', 'description': 'Planimetric analysis; Clinical assessment; Images; Image analysis;'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Burn wounds', 'Burns', 'Skin substitute'], 'conditions': ['Burns']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': '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;'}, 'identificationModule': {'nctId': 'NCT02350205', 'briefTitle': 'SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Quebec-Universite Laval'}, 'officialTitle': 'SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma.', 'orgStudyIdInfo': {'id': 'LOEX 014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (SASS)', 'description': 'Phase A: All patients will receive both Self assembled skin substitute (SASS) and Split-thickness autograft (paired samples sites A+ B). // Phase B: All patients will receive Self assembled skin subsitute (SASS)', 'interventionNames': ['Biological: Self assembled skin substitute (SASS)']}], 'interventions': [{'name': 'Self assembled skin substitute (SASS)', 'type': 'BIOLOGICAL', 'description': 'All patients in Phase B will receive Self assembled skin substitute (SASS)', 'armGroupLabels': ['Treatment (SASS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Vincent Gabriel, MD', 'role': 'CONTACT'}], 'facility': 'Foothill Medcial Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Edward Tredget, MD', 'role': 'CONTACT'}], 'facility': "Mackenzie Health Science's Centre", 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V6H 3V4', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sally Hynes, MD', 'role': 'CONTACT'}], 'facility': "BC Children's Hospital Plastic Surgery Clinic", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R3A 1R9', 'city': 'Winnipeg', 'state': 'Manitoba', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sarvesh Logsetty, MD', 'role': 'CONTACT'}], 'facility': 'Winnipeg Health Science Center', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Joel Fish, MD', 'role': 'CONTACT'}], 'facility': 'Hospital for Sick Children (Sickkids)', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Patricia Bortoluzzi, MD', 'role': 'CONTACT'}], 'facility': 'Hôpital Sainte Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1J 1Z4', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Chanel Beaudoin-Cloutier, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Québec - Unité des grands brûlés', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Veronique J Moulin, PhD', 'role': 'CONTACT', 'email': 'veronique.moulin@fmed.ulaval.ca', 'phone': '418-525-4444', 'phoneExt': '61715'}, {'name': 'Lucie Germain, PhD', 'role': 'CONTACT', 'email': 'lucie.germain@fmed.ulaval.ca', 'phone': '418-525-4444', 'phoneExt': '61696'}], 'overallOfficials': [{'name': 'Veronique J Moulin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Quebec'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Quebec-Universite Laval', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Veronique Moulin', 'investigatorAffiliation': 'CHU de Quebec-Universite Laval'}}}}