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

I

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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