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Clinical Trials/NCT00867295
NCT00867295
Completed
Phase 3

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

Istanbul University1 site in 1 country150 target enrollmentSeptember 2008
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ConditionsSolid Tumor
Interventionsplacebocefazolin Sodium
Drugscefazolin Sodiumplacebo

Overview

Phase
Phase 3
Intervention
placebo
Conditions
Solid Tumor
Sponsor
Istanbul University
Enrollment
150
Locations
1
Primary Endpoint
infectious complication
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
March 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Arms & Interventions

placebo

no antibiotic is used

Intervention: placebo

drug

cefazolin Sodium 1g i.v. before the operation

Intervention: cefazolin Sodium

Outcomes

Primary Outcomes

infectious complication

Time Frame: 30 days

Study Sites (1)

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