Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00867295

Acronym

TIVAD

Enrollment

150

Registered

2009-03-23

Start date

2008-09-30

Completion date

2010-03-31

Last updated

2010-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor

Keywords

implantable catheters, Indwelling Catheters, infection, cefazolin sodium, prophylactic, antibiotic, totally implantable venous access device, cancer patients

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.

Interventions

DRUGcefazolin Sodium

cefazolin Sodium 1g i.v. before operation

DRUGplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
infectious complication	30 days

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026