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

This study has been completed.
Sponsor:
Information provided by:
Istanbul University
ClinicalTrials.gov Identifier:
NCT00867295
First received: March 20, 2009
Last updated: June 1, 2010
Last verified: March 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Istanbul University

Additional 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
Study First Received: March 20, 2009
Last Updated: June 1, 2010
Health Authority: Turkey: Ministry of Health

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
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on September 18, 2014