Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device

Solid Tumor Clinical Trial

— TIVAD  

Official title:

A Randomized, Double-blind, Placebo-controlled Trial to Determine Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00867295
• Other study ID #: 2009/22
• Status: Completed
• Phase: Phase 3
• First received: March 20, 2009
• Last updated: June 1, 2010
• Start date: September 2008
• Est. completion date: March 2010

Study information

• Verified date: March 2009
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• cefazolin Sodium
cefazolin Sodium 1g i.v. before operation
• placebo
placebo

Locations

Country	Name	City	State
Turkey	Istanbul University Institute of Oncology	Istanbul	Capa

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infectious complication		30 days	Yes