Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device

Phase 3

Completed

• Conditions: Solid Tumor
• Interventions: Drug: cefazolin Sodium; Drug: placebo

• Registration Number: NCT00867295
• Lead Sponsor: Istanbul University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Status Verified: 2009-03
• Study First Submitted: 2009-03-20
• Study First Submitted QC: 2009-03-20
• Study First Posted: 2009-03-23
• Primary Completion: 2009-12
• Study Completion: 2010-03
• Last Update Submitted: 2010-06-01
• Last Update Posted: 2010-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drug	cefazolin Sodium	cefazolin Sodium 1g i.v. before the operation
placebo	placebo	no antibiotic is used

Primary Outcome Measures

Name	Time	Method
infectious complication	30 days

Trial Locations

Locations (1)

Istanbul University Institute of Oncology; 🇹🇷 Istanbul, Capa, Turkey