Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device - Full Text View

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

This study is currently recruiting participants.

Verified by Istanbul University, March 2009

First Received: March 20, 2009 No Changes Posted

Sponsor:	Istanbul University
Information provided by:	Istanbul University
ClinicalTrials.gov Identifier:	NCT00867295

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Antibiotics Cancer

Drug Information available for: Cefazolin Cefazolin sodium

U.S. FDA Resources

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
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
placebo: Placebo Comparator no antibiotic is used	Drug: placebo placebo
drug: Active Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867295

Contacts

Contact: Hasan Karanlik, MD

+905324025354

karanlik@istanbul.edu.tr

Locations

Turkey, Capa
Istanbul University Institute of Oncology	Recruiting
Istanbul, Capa, Turkey, 34190
Contact: Hasan Karanlik, MD karanlik@istanbul.edu.tr

Sponsors and Collaborators

Istanbul University

Investigators

Principal Investigator:

Hasan Karanlik, MD

Istanbul University Institute of Oncology Department of Surgery

More Information

No publications provided

Responsible Party:	Istanbul University Institute of Oncology ( Istanbul University Institute of Oncology (Hasan Karanlik, MD) )
Study ID Numbers:	2009/22
Study First Received:	March 20, 2009
Last Updated:	March 20, 2009
ClinicalTrials.gov Identifier:	NCT00867295 History of Changes
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-Infective Agents
Anti-Bacterial Agents
Cefazolin
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010