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

Istanbul University

Status and phase: Completed; Phase 3

Conditions: Solid Tumor

Treatments: Drug: cefazolin Sodium; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00867295

2009/22

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

no antibiotic is used

Treatment:

Drug: placebo

drug

Active Comparator group

Description:

cefazolin Sodium 1g i.v. before the operation

Treatment:

Drug: cefazolin Sodium