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Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device (TIVAD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00867295
First Posted: March 23, 2009
Last Update Posted: June 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Istanbul University
  Purpose
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.

Condition Intervention Phase
Solid Tumor Drug: cefazolin Sodium Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Trial to Determine Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device.

Resource links provided by NLM:


Further study details as provided by Istanbul University:

Primary Outcome Measures:
  • infectious complication [ Time Frame: 30 days ]

Estimated Enrollment: 150
Study Start Date: September 2008
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
no antibiotic is used
Drug: placebo
placebo
Active Comparator: drug
cefazolin Sodium 1g i.v. before the operation
Drug: cefazolin Sodium
cefazolin Sodium 1g i.v. before operation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Older than 18 years of age
  • Have solid tumor
  • White cells >4000
  • Platelets >100.000
  • Prothrombin time in normal range

Exclusion Criteria:

  • Drug allergy
  • Diabetes mellitus
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867295


Locations
Turkey
Istanbul University Institute of Oncology
Istanbul, Capa, Turkey, 34190
Sponsors and Collaborators
Istanbul University
Investigators
Principal Investigator: Hasan Karanlik, MD Istanbul University Institute of Oncology Department of Surgery
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Istanbul University Institute of Oncology (Hasan Karanlik, MD), Istanbul University Institute of Oncology
ClinicalTrials.gov Identifier: NCT00867295     History of Changes
Other Study ID Numbers: 2009/22
First Submitted: March 20, 2009
First Posted: March 23, 2009
Last Update Posted: June 2, 2010
Last Verified: March 2009

Keywords provided by Istanbul University:
implantable catheters
Indwelling Catheters
infection
cefazolin sodium
prophylactic
antibiotic
totally implantable venous access device
cancer patients

Additional relevant MeSH terms:
Anti-Bacterial Agents
Cefazolin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents