A Randomized, Double-blind, Placebo-controlled Trial to Determine Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device.
Phase 3
18 Years
90 Years
18 Years
90 Years
Not Enrolling
Both
Solid Tumor
Both
Solid Tumor
Trial Information
A Randomized, Double-blind, Placebo-controlled Trial to Determine Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
infectious complication
Outcome Time Frame:
30 days
Safety Issue:
Yes
Principal Investigator
Hasan Karanlik, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Istanbul University Institute of Oncology Department of Surgery
Authority:
Turkey: Ministry of Health
Study ID:
2009/22
NCT ID:
NCT00867295
Start Date:
September 2008
Completion Date:
March 2010
Related Keywords:
- Solid Tumor
- implantable catheters
- Indwelling Catheters
- infection
- cefazolin sodium
- prophylactic
- antibiotic
- totally implantable venous access device
- cancer patients
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