Clinical trial · Interventional
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.
NCT00867295CI-TRIAL-00003504TIVADcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cefazolin Sodium | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- no antibiotic is used
- interventionNames
- Drug: placebo
- type
- ACTIVE_COMPARATOR
- label
- drug
- description
- cefazolin Sodium 1g i.v. before the operation
- interventionNames
- Drug: cefazolin Sodium
Primary outcomes (1)
- measure
- infectious complication
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKaranlik H, Kurul S, Saip P, Unal ES, Sen F, Disci R, Topuz E. The role of antibiotic prophylaxis in totally implantable venous access device placement: results of a single-center prospective randomized trial. Am J Surg. 2011 Jul;202(1):10-5. doi: 10.1016/j.amjsurg.2010.05.005. Epub 2011 May 23. PMID 21601826