Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-01-04 @ 5:27 PM
Study NCT ID:
NCT00259350
Status:
COMPLETED
Last Update Posted:
2009-01-27
First Post:
2005-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chlorhexidine vs Povidone Iodine in Alcoholic Solutions for Prevention of Central Venous Catheter Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 520}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2006-04'}, 'lastUpdateSubmitDate': '2009-01-26', 'studyFirstSubmitDate': '2005-11-27', 'studyFirstSubmitQcDate': '2005-11-27', 'lastUpdatePostDateStruct': {'date': '2009-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention of catheter colonization'}], 'secondaryOutcomes': [{'measure': 'Prevention of catheter related bacteremia'}, {'measure': 'Prevention of a positive culture of the catheter whaterver the threshold'}, {'measure': 'Local and general tolerance'}]}, 'conditionsModule': {'keywords': ['Central venous catheter', 'Skin disinfection', 'Antisepsis', 'Nosocomial infection', 'Catheter infection'], 'conditions': ['ICU Patients Requiring a Central Venous Access']}, 'referencesModule': {'references': [{'pmid': '17954800', 'type': 'DERIVED', 'citation': 'Mimoz O, Villeminey S, Ragot S, Dahyot-Fizelier C, Laksiri L, Petitpas F, Debaene B. Chlorhexidine-based antiseptic solution vs alcohol-based povidone-iodine for central venous catheter care. Arch Intern Med. 2007 Oct 22;167(19):2066-72. doi: 10.1001/archinte.167.19.2066.'}]}, 'descriptionModule': {'briefSummary': 'The best antiseptic solution for cateheter care remains unknown.High concentration in aquous solution or low concentration in alcoholic solution of chlorhexidine actbetter than povidone iodine in aquous solutions. No study has compare alcoholic formulations of low concentration of chlorhexidine and povidone iodine for skin disinfection prior to insertion of central venous catheters.\n\nTo compare the incidence of central venous catheter colonization after skin disinfection with either an alcoholic solution of povidone iodine or a combination of 0.5% chlorhexidine, 0.025% Benzalkonium and 4% benzylic alcohol.\n\nTo compare the incidence of catheter related bacteremia in the to study groups. To compare the local and general tolerance of the two antiseptic formulations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 yeras of age\n* Requiring an internal jugular or sub-clavian central venous catheter for their care during at least 72 h\n* Informed consent signed up\n\nExclusion Criteria:\n\n* Bacteriemic infection not under control\n* extensive cutaneous infection\n* Women with childbearing potential'}, 'identificationModule': {'nctId': 'NCT00259350', 'briefTitle': 'Chlorhexidine vs Povidone Iodine in Alcoholic Solutions for Prevention of Central Venous Catheter Infection', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Prevention of Central Venous Catheter Infections : Comparison of the Efficacy of Skin Disinfection With 5% Povidone Iodine in Alcoholic Solution Versus 0.25% Chlorhexidine, 0.025 Benzalkonium and 4% Benzylic Alcohol', 'orgStudyIdInfo': {'id': 'Anticath'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Skin disinfection', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '86021', 'city': 'Poitiers', 'state': 'Vienne', 'country': 'France', 'facility': 'University hospital', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'overallOfficials': [{'name': 'Olivier MIMOZ, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital of Poitiers, france'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}}}}