Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-03 @ 7:58 PM
Study NCT ID:
NCT00867295
Status:
COMPLETED
Last Update Posted:
2010-06-02
First Post:
2009-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002437', 'term': 'Cefazolin'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-01', 'studyFirstSubmitDate': '2009-03-20', 'studyFirstSubmitQcDate': '2009-03-20', 'lastUpdatePostDateStruct': {'date': '2010-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'infectious complication', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['implantable catheters', 'Indwelling Catheters', 'infection', 'cefazolin sodium', 'prophylactic', 'antibiotic', 'totally implantable venous access device', 'cancer patients'], 'conditions': ['Solid Tumor']}, 'referencesModule': {'references': [{'pmid': '21601826', 'type': 'DERIVED', 'citation': 'Karanlik H, Kurul S, Saip P, Unal ES, Sen F, Disci R, Topuz E. The role of antibiotic prophylaxis in totally implantable venous access device placement: results of a single-center prospective randomized trial. Am J Surg. 2011 Jul;202(1):10-5. doi: 10.1016/j.amjsurg.2010.05.005. Epub 2011 May 23.'}]}, 'descriptionModule': {'briefSummary': 'This randomized trial is determining the role of antibiotic prophylaxis in the prevention of the infectious complications in patients carrying out totally implantable venous access device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years of age\n* Have solid tumor\n* White cells \\>4000\n* Platelets \\>100.000\n* Prothrombin time in normal range\n\nExclusion Criteria:\n\n* Drug allergy\n* Diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT00867295', 'acronym': 'TIVAD', 'briefTitle': 'Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Trial to Determine Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device.', 'orgStudyIdInfo': {'id': '2009/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'no antibiotic is used', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'drug', 'description': 'cefazolin Sodium 1g i.v. before the operation', 'interventionNames': ['Drug: cefazolin Sodium']}], 'interventions': [{'name': 'cefazolin Sodium', 'type': 'DRUG', 'description': 'cefazolin Sodium 1g i.v. before operation', 'armGroupLabels': ['drug']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34190', 'city': 'Istanbul', 'state': 'Capa', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University Institute of Oncology', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Hasan Karanlik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul University Institute of Oncology Department of Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Istanbul University Institute of Oncology (Hasan Karanlik, MD)', 'oldOrganization': 'Istanbul University Institute of Oncology'}}}}