Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-19 @ 9:01 AM
Study NCT ID:
NCT02278718
Status:
COMPLETED
Last Update Posted:
2024-09-27
First Post:
2014-10-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Bulgaria', 'Czechia', 'France', 'Israel', 'Sweden']}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kerend@mediwound.com', 'phone': '972-77-9714103', 'title': 'Keren David Zarbiv', 'organization': 'MediWound'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Time of informed consented until subject's study completion (12 months post wound closure) or earlier if early termination from study.", 'description': "An adverse event is an undesirable or unintentional event that occurs during use of the study Drug, whether or not considered related to the Drug; this includes clinically significant changes in laboratory values and therapeutic failures. Regardless of the severity or relationship to the investigational Drug, all adverse events occurring during the study period should be recorded in a subject's CRFs.", 'eventGroups': [{'id': 'EG000', 'title': 'NexoBrid Gel', 'description': 'NexoBrid Gel is applied to the burn wound at a dose of 2g or 5g NexoBrid sterile powder mixed with 20g or 50g sterile Gel Vehicle per 180cm\\^2 of TBSA for four hours.\n\nNexoBrid: NexoBrid is an enzymatic debriding agent for Eschar Removal.', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 31, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Non surgical and Surgical Debridement\n\nStandard of Care: Surgical or Non-Surgical methods for Eschar Removal', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 30, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'notes': 'General Disorders and Administration Site Conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinovirus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemoglobin Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bromhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Systemic Inflammatory Response Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Withdrawal Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint Contracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Laryngospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Complete Eschar Removal (in Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NexoBrid Gel', 'description': 'NexoBrid Gel is applied to the burn wound at a dose of 2g or 5g NexoBrid sterile powder mixed with 20g or 50g sterile Gel Vehicle per 180cm\\^2 of TBSA for four hours.\n\nNexoBrid: NexoBrid is an enzymatic debriding agent for Eschar Removal.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Non surgical and Surgical Debridement\n\nStandard of Care: Surgical or Non-Surgical methods for Eschar Removal'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.88', 'upperLimit': '1.4'}, {'value': '5.99', 'groupId': 'OG001', 'lowerLimit': '2.71', 'upperLimit': '9.84'}]}]}], 'analyses': [{'pValue': '0.0008', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Wilcoxon test statistic was estimated using generalized Wilcoxon-Gehan test stratified by center group, age group, % TBSA group, proportion of FT area group and number of TWs group. A negative (positive) statistic is associated with longer (shorter) time to the event when treated with NexoBrid vs. Standard of Care. P-value was calculated using the re-randomization test.', 'statisticalMethod': 'Generalized Wilcoxon-Gehan Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization date until complete eschar removal. For NexoBrid, assessed post application (post 2 h soaking) and for SOC assessed immediately post last dressing change for non-surgical SOC arm and immediately post excision for surgical SOC arm.', 'description': 'Measured by a survival analysis of incidence of complete eschar removal as a function of time.\n\nEschar removal will be measured at the end of the debridement starting from randomization date, assessed until complete eschar removal is achieved (in days)', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who were randomised into the study.'}, {'type': 'SECONDARY', 'title': 'Incidence of Surgical Excision Performed for Eschar Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NexoBrid Gel', 'description': 'NexoBrid Gel is applied to the burn wound at a dose of 2g or 5g NexoBrid sterile powder mixed with 20g or 50g sterile Gel Vehicle per 180cm\\^2 of TBSA for four hours.\n\nNexoBrid: NexoBrid is an enzymatic debriding agent for Eschar Removal.'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Non surgical and Surgical Debridement\n\nStandard of Care: Surgical or Non-Surgical methods for Eschar Removal'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.025', 'ciLowerLimit': '0.007', 'ciUpperLimit': '0.090', 'groupDescription': 'Incidence of Surgical Excision for Eschar Removal for NexoBrid vs SOC', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Until complete eschar removal has been achieved. Complete eschar removal was achieved within 0.99 days (95% CI: 0.88 to 1.04) for the NexoBrid treatment arm and 5.99 days (95% CI: 2.71 to9.84) for the SOC treatment arm.', 'description': 'Number of patients who needed surgical excision for eschar removal', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Incidence Rate = The proportion and number of patients who required surgical excision for eschar removal.'}, {'type': 'SECONDARY', 'title': 'Blood Loss Related to Eschar Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NexoBrid Gel', 'description': 'NexoBrid Gel is applied to the burn wound at a dose of 2g or 5g NexoBrid sterile powder mixed with 20g or 50g sterile Gel Vehicle per 180cm\\^2 of TBSA for four hours.\n\nNexoBrid: NexoBrid is an enzymatic debriding agent for Eschar Removal.'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'Non surgical and Surgical Debridement\n\nStandard of Care: Surgical or Non-Surgical methods for Eschar Removal'}], 'classes': [{'categories': [{'measurements': [{'value': '32.26', 'spread': '284.757', 'groupId': 'OG000'}, {'value': '202.55', 'spread': '409.147', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1374', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Hematocrit - immediately before each procedure and 4 hrs after its completion. The amount of blood transfused will be summed over all transfusions carried out during the debridement procedure and up to 24 hrs from the end time of the debridement procedure', 'description': 'Measured by actual blood loss \\[ABL\\]. Actual blood loss was the calculated blood loss summed over all procedures carried out to remove eschar, using hematocrit values measured immediately before each procedure and 4 hours after its completion and the amount of blood transfused was summed over all transfusions carried out during the debridement procedure and up to 24 hours from the end time of the debridement procedure.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): 145 patients'}, {'type': 'SECONDARY', 'title': 'Percent Area of Autograft Performed in DPT Wounds - Main Analysis, Patient Level.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NexoBrid Gel', 'description': 'NexoBrid Gel is applied to the burn wound at a dose of 2g or 5g NexoBrid sterile powder mixed with 20g or 50g sterile Gel Vehicle per 180cm\\^2 of TBSA for four hours.\n\nNexoBrid: NexoBrid is an enzymatic debriding agent for Eschar Removal.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Non surgical and Surgical Debridement\n\nStandard of Care: Surgical or Non-Surgical methods for Eschar Removal'}], 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'spread': '38.57', 'groupId': 'OG000'}, {'value': '22.8', 'spread': '43.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5045', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-6.9', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Assessment will be performed by the investigator immediately after each autograft procedure was performed, before application of coverage.', 'description': 'Percent area of deep partial thickness wounds autografted', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, Patients with at least one DPT target wound.'}, {'type': 'SECONDARY', 'title': 'Incidence of Autograft Performed in Deep Partial Thickness Wounds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}, {'units': 'Deep Partial Thickness Wounds', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NexoBrid Gel', 'description': 'NexoBrid Gel is applied to the burn wound at a dose of 2g or 5g NexoBrid sterile powder mixed with 20g or 50g sterile Gel Vehicle per 180cm\\^2 of TBSA for four hours.\n\nNexoBrid: NexoBrid is an enzymatic debriding agent for Eschar Removal.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Non surgical and Surgical Debridement\n\nStandard of Care: Surgical or Non-Surgical methods for Eschar Removal'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0545', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.414', 'ciLowerLimit': '0.163', 'ciUpperLimit': '1.054', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': "Patient's wounds were assessed until complete healing of all wounds, during the period from complete eschar removal was achieved until complete wound closure. Median time in the population was approx. 4.5 weeks and longest follow up period was of 12 weeks", 'description': 'Number of autografts performed in deep partial thickness wounds', 'unitOfMeasure': 'autographs performed', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Deep Partial Thickness Wounds', 'denomUnitsSelected': 'Deep Partial Thickness Wounds', 'populationDescription': 'Main Analysis, Target Wound Level, Deep Partial Thickness Target Wounds Only'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NexoBrid Gel', 'description': 'NexoBrid Gel is applied to the burn wound at a dose of 2g or 5g NexoBrid sterile powder mixed with 20g or 50g sterile Gel Vehicle per 180cm\\^2 of TBSA for four hours.\n\nNexoBrid: NexoBrid is an enzymatic debriding agent for Eschar Removal.'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Non surgical and Surgical Debridement\n\nStandard of Care: Surgical or Non-Surgical methods for Eschar Removal'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'Number of Patients Completed 12 Month FU', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'The patient was randomised but did not receive study drug treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Out of 153 patients that were screened for enrollment, 145 patients were enrolled, randomized and included in FAS analysis. Seven patients were excluded at screening and one patient withdrew consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NexoBrid Gel', 'description': 'NexoBrid Gel is applied to the burn wound at a dose of 2g or 5g NexoBrid sterile powder mixed with 20g or 50g sterile Gel Vehicle per 180cm\\^2 of TBSA for four hours.\n\nNexoBrid: NexoBrid is an enzymatic debriding agent for Eschar Removal.'}, {'id': 'BG001', 'title': 'Standard of Care (SOC)', 'description': 'Non surgical and Surgical Debridement\n\nStandard of Care: Surgical or Non-Surgical methods for Eschar Removal'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age (years)', 'categories': [{'measurements': [{'value': '5.71', 'spread': '4.838', 'groupId': 'BG000'}, {'value': '5.83', 'spread': '4.909', 'groupId': 'BG001'}, {'value': '5.77', 'spread': '4.857', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '16.88', 'spread': '4.368', 'groupId': 'BG000'}, {'value': '17.09', 'spread': '4.108', 'groupId': 'BG001'}, {'value': '16.99', 'spread': '4.226', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Overall, 153 patients were screened for enrolment (Enrolled Set). Of the 153 patients enrolled, 145 patients were randomised and included in the FAS: 72 in the NexoBrid treatment arm and 73 in the SOC treatment arm.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-16', 'size': 259876, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-04T05:41', 'hasProtocol': True}, {'date': '2021-06-01', 'size': 1555595, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-04T06:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-25', 'studyFirstSubmitDate': '2014-10-27', 'resultsFirstSubmitDate': '2024-02-08', 'studyFirstSubmitQcDate': '2014-10-28', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-25', 'studyFirstPostDateStruct': {'date': '2014-10-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Complete Eschar Removal (in Days)', 'timeFrame': 'From randomization date until complete eschar removal. For NexoBrid, assessed post application (post 2 h soaking) and for SOC assessed immediately post last dressing change for non-surgical SOC arm and immediately post excision for surgical SOC arm.', 'description': 'Measured by a survival analysis of incidence of complete eschar removal as a function of time.\n\nEschar removal will be measured at the end of the debridement starting from randomization date, assessed until complete eschar removal is achieved (in days)'}], 'secondaryOutcomes': [{'measure': 'Incidence of Surgical Excision Performed for Eschar Removal', 'timeFrame': 'Until complete eschar removal has been achieved. Complete eschar removal was achieved within 0.99 days (95% CI: 0.88 to 1.04) for the NexoBrid treatment arm and 5.99 days (95% CI: 2.71 to9.84) for the SOC treatment arm.', 'description': 'Number of patients who needed surgical excision for eschar removal'}, {'measure': 'Blood Loss Related to Eschar Removal', 'timeFrame': 'Hematocrit - immediately before each procedure and 4 hrs after its completion. The amount of blood transfused will be summed over all transfusions carried out during the debridement procedure and up to 24 hrs from the end time of the debridement procedure', 'description': 'Measured by actual blood loss \\[ABL\\]. Actual blood loss was the calculated blood loss summed over all procedures carried out to remove eschar, using hematocrit values measured immediately before each procedure and 4 hours after its completion and the amount of blood transfused was summed over all transfusions carried out during the debridement procedure and up to 24 hours from the end time of the debridement procedure.'}, {'measure': 'Percent Area of Autograft Performed in DPT Wounds - Main Analysis, Patient Level.', 'timeFrame': 'Assessment will be performed by the investigator immediately after each autograft procedure was performed, before application of coverage.', 'description': 'Percent area of deep partial thickness wounds autografted'}, {'measure': 'Incidence of Autograft Performed in Deep Partial Thickness Wounds', 'timeFrame': "Patient's wounds were assessed until complete healing of all wounds, during the period from complete eschar removal was achieved until complete wound closure. Median time in the population was approx. 4.5 weeks and longest follow up period was of 12 weeks", 'description': 'Number of autografts performed in deep partial thickness wounds'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Thermal Burns']}, 'referencesModule': {'references': [{'pmid': '24074719', 'type': 'BACKGROUND', 'citation': 'Rosenberg L, Krieger Y, Bogdanov-Berezovski A, Silberstein E, Shoham Y, Singer AJ. A novel rapid and selective enzymatic debridement agent for burn wound management: a multi-center RCT. Burns. 2014 May;40(3):466-74. doi: 10.1016/j.burns.2013.08.013. Epub 2013 Sep 26.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/?term=nexobrid', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study will be a two-arms study intending to demonstrate superiority of NexoBrid treatment over SOC in children with thermal burns. The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard of care (SOC).', 'detailedDescription': "A total of 160 patients will be randomized into NexoBrid and SOC treatment (80 patients per arm).\n\nAge distribution will be managed as follows:\n\n* 45 patients 0-23 months old\n* 45 patients 24 months-3 years old\n* 30 patients 4-11 years old\n* 20 patients 12-17 years old The remaining 20 patients will be enrolled to any of the above groups, per their age during enrollment.\n\nThe study will be conducted in three stages. In Stage I, at least 24 children age 4-18 years, hospitalized in burn units, with deep partial thickness burns ranging from 1%-30% TBSA, and who meet the entrance criteria, will be enrolled. Upon completion of stage I, a safety analysis will be performed on safety parameters and the results will be evaluated by a Data Safety Monitoring Board (DSMB) as defined in the agreed charter. If the DSMB does not have any safety concerns, Stage II will commence, this time enrolling at least 26 additional children aged of 1-18 years according to the study procedures. A DSMB will be convened to assess the safety data of the first 50 patients enrolled at stages 1 \\& 2. If the DSMB has not found any safety concerns, stage III will commence in which patients from the age of birth to 18 years will be included (stage III will include 110 remaining patients required to reach a total of 160 patients).\n\nFollowing the enrollment of a subject to the study and prior to randomization, physicians will define one or more Target Wounds (TWs) per subject according to TWs definition. All subjects' DPT and FT burns that fit the specified criteria are intended to receive study treatment per randomized study arm and therefore, must be designated as TWs.\n\nPrior to eschar removal treatment with NexoBrid or SOC subjects will be medicated with appropriate analgesia and undergo wound cleansing and dressing of all wounds with antibacterial solutions. Following wound cleansing and antibacterial treatments, subjects will undergo the eschar removal process as per treatment assignment (NexoBrid or SOC, following randomization). Subsequent to eschar removal, all wounds will be assessed and treated in the same manner, in accordance with post-eschar removal wound care strategy. Furthermore, subjects will undergo daily assessments (Vital signs (VS) and pain assessments) for one week and weekly assessments thereafter, until wound closure. Following wound closure, subjects will be followed up at 6 weeks, 12 weeks, and after that, at 6, 12, 18 and 24 months (for a blinded assessment of cosmesis, function and QoL evaluation).\n\nAll subjects will be invited to one additional extended follow up visit that will occur at least 30 months after wound closure confirmation for a blinded assessment of cosmesis, function and QoL evaluation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Stage 1: Males and females between 4 years to 18 years of age, Stage 2 (upon DSMB review): Males and females between 1 year to 18 years of age, Stage 3 (upon DSMB review): Males and females between 0 years to 18 years of age.\n2. Thermal burns caused by fire/flame, scalds or contact.\n3. Patient total burns area ≥ 1% DPT and / or FT,\n4. Patient total burns area should be ≤ 30% TBSA; SPT, DPT and/or FT in depth,\n5. Signed written informed consent by a legal guardian can be obtained within 84 hours of the burn injury.\n\nAt least one wound (a continuous burn area which can be treated in one session; might include several anatomical areas) in a patient should meet all following criteria:\n\n1. Wound that is ≥ 1% TBSA (DPT and/or FT) (not including face, perineal or genital),\n2. Wound is composed of DPT and/or FT in depth. Superficial partial thickness areas may be included in the wound area only if cannot be separated from deeper areas (e.g. surrounded by or mixed with DPT areas) and might interfere with the treatment of the deeper areas,\n3. Wound that is potentially intended for surgical eschar removal,\n4. Wound's blisters can be unroofed, as judged by the investigator.\n\nExclusion Criteria:\n\n1. Patients weighing less than 3kg,\n2. Patients who are unable to follow study procedures and follow up period,\n3. Patients with electrical or chemical burns,\n4. Patient with a continuous burn area above 15% TBSA,\n5. Patients with no DPT and/or FT burn area (only SPT wounds),\n6. Patient with circumferential anterior/posterior trunk fire/flame burns, \\>15% TBSA (Circumferential is defined as encircling ≥ 80% of the trunk circumference),\n7. The following pre-enrolment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3),\n8. Patients with diagnosed infections,\n9. Diagnosis of smoke inhalation injury,\n10. Patients with pre-enrolment wounds which are covered by eschar saturated with iodine or by SSD pseudoeschar (e.g. pseudoeschar as a result of \\>12h SSD treatment),\n11. Patients with pre-enrolment escharotomy,\n12. Pregnant women (positive pregnancy test) or nursing mothers,\n13. Poorly controlled diabetes mellitus (HbA1c\\>9%),\n14. Known Cardio-pulmonary disease, oxygen-dependent pulmonary diseases, broncho-pneumonia, uncontrolled asthma,\n15. Known conditions which interfere with circulation (peripheral vascular disease, edema, lymphedema, surgery to the regional lymph nodes, obesity),\n16. Any known conditions that would preclude safe participation in the study or adding further risk to the basic acute burn trauma (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, pulmono-cardiovascular, liver or neoplastic disease),\n17. ASA greater than 2\n18. Chronic systemic steroid intake,\n19. History of allergy and/or known sensitivity to pineapples, papaya, Bromelain or papain,\n20. Current (within 12 months prior to screening) suicide attempt,\n21. Enrollment in any investigational drug trial within 4 weeks prior to screening,\n22. Current (within 12 months prior to screening) alcohol (daily consumption \\> 3 units for males and \\>2 units for females) or drug abuse,\n23. Prisoners and incarcerated\n24. Patients who might depend on the clinical study site or investigator.\n25. Patient expresses objection to participate in the study.\n26. Patients with other severe cutaneous trauma at the same sites as the burns (i.e. blunt, avulsion or deep abrasion) or previous burn(s) at the same treatment site(s)\n27. General condition of patient would contraindicate surgery"}, 'identificationModule': {'nctId': 'NCT02278718', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care', 'organization': {'class': 'INDUSTRY', 'fullName': 'MediWound Ltd'}, 'officialTitle': 'A Multicenter, Multinational, Randomized, Controlled, Open Label Study, Performed in Children With Thermal Burns, to Evaluate the Efficacy and Safety of NexoBrid as Compared to Standard of Care (SOC) Treatment', 'orgStudyIdInfo': {'id': 'MW2012-01-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NexoBrid Gel', 'description': 'NexoBrid Gel is applied to the burn wound at a dose of 2g or 5g NexoBrid sterile powder mixed with 20g or 50g sterile Gel Vehicle per 180cm\\^2 of TBSA for four hours.', 'interventionNames': ['Drug: NexoBrid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Non surgical and Surgical Debridement', 'interventionNames': ['Procedure: Standard of Care']}], 'interventions': [{'name': 'NexoBrid', 'type': 'DRUG', 'description': 'NexoBrid is an enzymatic debriding agent for Eschar Removal.', 'armGroupLabels': ['NexoBrid Gel']}, {'name': 'Standard of Care', 'type': 'PROCEDURE', 'description': 'Surgical or Non-Surgical methods for Eschar Removal', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85008', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Maricopa Special Health Care District', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University Of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33146', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33620', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'The University of South Florida Board of Trustees', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center Research Institute, Inc.', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Shriners Hospital for Children', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University Medical Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '97232', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Legacy Emanuel Hospital & Health Center dba Legacy Research Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19134', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Drexel University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425s', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': "Shawn Jekins Children's Hospital", 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'B 9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital, Department of Plastic Surgery', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '0179', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'S. Khechinashvili University Hospital', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '12683', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Unfallkrankenhaus Berlin Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-70176', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Klinikum Stuttgart - Olgahospital', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': 'H-1146', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'MRE Bethesda Gyermekkórháza', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': 'H-3526', 'city': 'Miskolc', 'country': 'Hungary', 'facility': 'B.A.Z Megyei Kórház és Egyetemi Oktatókórház', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'zip': 'H-7624', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'Klinikai Kozpont Gyermekgyogyaszati Klinika', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '110001', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Dr. Ram Manohar Lohia Hospital, Baba Kharak Singh Marg', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '570001', 'city': 'Mysuru', 'country': 'India', 'facility': 'Krishna Rajendra Hospital', 'geoPoint': {'lat': 12.29791, 'lon': 76.63925}}, {'zip': '110029', 'city': 'New Delhi', 'country': 'India', 'facility': 'Vardhman Mahavir Medical College (VLCC) and Safdarjung Hospital', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '37126', 'city': 'Verona', 'country': 'Italy', 'facility': 'Universitary Integrated Hospital Verona (AOUI Verona),', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '1942', 'city': 'Beverwijk', 'country': 'Netherlands', 'facility': 'Acute Burn Care &Trauma Surgery, Dept Surgery/Burn Center, Rode Kruis Ziekenhuis, LUMC University Leiden', 'geoPoint': {'lat': 52.48333, 'lon': 4.65694}}, {'zip': '30-663', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Uniwersytecki Szpital Dzieciecy w Krakowie', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Szpital Dzieciecy im.prof.dr.med Jana Bogdanowicza, Oddzial Chirurgii i Urologii Dzieciecej z Pododdzialem Leczenia Oparzen', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '700309', 'city': 'Iași', 'country': 'Romania', 'facility': 'Spitalul Clinic de Urgenta pentru Copii "Sfanta Maria"', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '54000', 'city': 'Târgu Mureş', 'country': 'Romania', 'facility': 'Spitalul Clinic de Urgenta Tg- Mures', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'zip': '826 06', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Univerzitná nemocnica Bratislava, Klinika popálenin a rekonštrukčnej chirurgie', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'La Paz University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Boulevar Sur s/n', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '61103', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'CNPE "City clinical hospital of immediate and urgent medical aid n.a.Meshchaninov" of Kharkiv CC and State institution \'Zaitsev V.T. Institute of general and urgent surgery of the National academy of medical sciences of Ukraine\'', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '65049', 'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Communal institution "Odessa Regional Clinical Medical Center"', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Birmingham Children´s Hospital NHS Foundation Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': "Royal Manchester Children's Hospital", 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Lior Rosenberg, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'MediWound Ltd'}, {'name': 'Yaron Shoham, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MediWound Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MediWound Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}