Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device (TIVAD)
This study has been completed.
Sponsor:
Istanbul University
Information provided by:
Istanbul University
ClinicalTrials.gov Identifier:
NCT00867295
First received: March 20, 2009
Last updated: June 1, 2010
Last verified: March 2009
| Tracking Information | |||||
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| First Received Date ICMJE | March 20, 2009 | ||||
| Last Updated Date | June 1, 2010 | ||||
| Start Date ICMJE | September 2008 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
infectious complication [ Time Frame: 30 days ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00867295 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device | ||||
| Official Title ICMJE | A Randomized, Double-blind, Placebo-controlled Trial to Determine Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device. | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Solid Tumor | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | 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. Epub 2011 May 23. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Completion Date | March 2010 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Turkey | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00867295 | ||||
| Other Study ID Numbers ICMJE | 2009/22 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Istanbul University Institute of Oncology (Hasan Karanlik, MD), Istanbul University Institute of Oncology | ||||
| Study Sponsor ICMJE | Istanbul University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Istanbul University | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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