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 has been completed.

First Received on March 20, 2009. Last Updated on June 1, 2010 History of Changes

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 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:

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
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

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):

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.

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
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 24, 2012