Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT00389558
Status:
COMPLETED
Last Update Posted:
2009-09-21
First Post:
2006-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antiseptic Use and Dressing Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000583', 'term': 'Amikacin'}], 'ancestors': [{'id': 'D007612', 'term': 'Kanamycin'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 453}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-18', 'studyFirstSubmitDate': '2006-10-17', 'studyFirstSubmitQcDate': '2006-10-17', 'lastUpdatePostDateStruct': {'date': '2009-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy on skin colonization of two commercially available antiseptics', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'In case of nosocomial infection, relationship with skin bacteria', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Skin colonization', 'Antiseptic', 'Epicutaneocavous catheter dressing', 'Infant'], 'conditions': ['Skin Colonization', 'Catheterization', 'Bacterial Infection']}, 'referencesModule': {'references': [{'pmid': '11519913', 'type': 'BACKGROUND', 'citation': 'Mahieu LM, De Dooy JJ, De Muynck AO, Van Melckebeke G, Ieven MM, Van Reempts PJ. Microbiology and risk factors for catheter exit-site and -hub colonization in neonatal intensive care unit patients. Infect Control Hosp Epidemiol. 2001 Jun;22(6):357-62. doi: 10.1086/501913.'}]}, 'descriptionModule': {'briefSummary': 'The purposes of the study are:\n\n1. To compare the local efficacy (skin colonization) of 2 commercialized antiseptics used for the disinfection of the dressing application for an epicutaneocavous catheter (EPI).\n2. To evaluate whether the bacteria responsible for nosocomial infection is comparable to the flora diagnosed at the EPI site.', 'detailedDescription': 'Epicutaneocavous catheter is a significant risk factor for nosocomial infection in newborn infants. These infections have been related to local bacterial colonisation. Therefore thorough disinfection should lower the risk of nosocomial infection. However, the local efficacy of antiseptic use has not yet been clearly evaluated in this situation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All infants admitted to the Neonatal Intensive Care Unit\n* Epicutaneocavous catheter insertion indication\n\nExclusion Criteria:\n\n* Epicutaneocavous catheter not inserted within the Unit'}, 'identificationModule': {'nctId': 'NCT00389558', 'briefTitle': 'Antiseptic Use and Dressing Application', 'organization': {'class': 'OTHER', 'fullName': 'Maternite Regionale Universitaire'}, 'officialTitle': 'Comparison of Amukin Versus Biseptine Use for Dressing Application of Epicutaneocavous Catheters for Nosocomial Infection Prevention', 'orgStudyIdInfo': {'id': 'MRAP190406'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Biseptine', 'interventionNames': ['Procedure: disinfection efficacy using Biseptine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Amukin', 'interventionNames': ['Procedure: disinfection efficacy using Amukin']}], 'interventions': [{'name': 'disinfection efficacy using Biseptine', 'type': 'PROCEDURE', 'otherNames': ['Biseptine'], 'description': 'Detersion and antiseptic application when changing catheter dressing', 'armGroupLabels': ['2']}, {'name': 'disinfection efficacy using Amukin', 'type': 'PROCEDURE', 'otherNames': ['Amukin'], 'description': 'Detersion and antiseptic application when changing catheter dressing', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54042', 'city': 'Nancy', 'country': 'France', 'facility': 'Maternite Regionale Universitaire', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Jean-Michel HASCOET, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of NANCY, France'}, {'name': 'Monique LUX, Pharmacist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maternite Regionale Universitaire'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maternite Regionale Universitaire', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof JM HASCOET', 'oldOrganization': 'Maternite Regionale Universitaire'}}}}