Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-03-02 @ 9:03 AM
Study NCT ID:
NCT04124133
Status:
COMPLETED
Last Update Posted:
2019-10-11
First Post:
2019-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Efficacy and Safety of Ialuset Cream and Gauze in Second-degree Burns on Child
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001458', 'term': 'Bandages'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-10', 'studyFirstSubmitDate': '2019-10-10', 'studyFirstSubmitQcDate': '2019-10-10', 'lastUpdatePostDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient rate with complete healing', 'timeFrame': '21 days', 'description': 'pourcentage of patient with 100% of reepithelilisation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Second-degree Burn of Children']}, 'descriptionModule': {'briefSummary': 'Observational retrospective monocentric study occured in the univeristy hospital center of Bensançon the department of pediatric surgery.\n\nData of patients treated in the hospital between January 2016 and January 2019 have been collected.', 'detailedDescription': 'Coordinator investigator have put in place a protocol care for children with second degree burns since 2016.\n\nIt consists in detersion and cleaning of wound, application of ialuset cream and gauzepad (hyaluronic acid) during 21 days. After 21 days if patients are not healed, physician consider to perform grafting'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children from 1month to 15 years with a second degree burn', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* second-degree burns\n* less than 20% of the body surface\n* less than 15 years old\n* treated within 24 hours\n* 1st line of treatment with ialuset\n* treated at the center between 2016 and 2019\n\nExclusion Criteria:\n\n* patient who refused data collection'}, 'identificationModule': {'nctId': 'NCT04124133', 'briefTitle': 'Evaluation of Efficacy and Safety of Ialuset Cream and Gauze in Second-degree Burns on Child', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Genévrier'}, 'officialTitle': 'Observational Retrospective Study Evaluating Efficacy and Safety of Ialuset Cream or Gauzepad in Second Degree Burns Use for Children', 'orgStudyIdInfo': {'id': 'CHILD study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'dressing with hyaluronic acid', 'type': 'DEVICE', 'description': 'Application of ialuset cream or gauzepad (hyaluronic acid)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Besançon', 'country': 'France', 'facility': 'CHU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'overallOfficials': [{'name': 'Arnaud Fotso Kamdem', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Besançon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Genévrier', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}