NCT00867295

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 23, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

June 2, 2010

Status Verified

March 1, 2009

Enrollment Period

1.2 years

First QC Date

March 20, 2009

Last Update Submit

June 1, 2010

Conditions

Solid Tumor

Keywords

implantable cathetersIndwelling Cathetersinfectioncefazolin sodiumprophylacticantibiotictotally implantable venous access devicecancer patients

Outcome Measures

Primary Outcomes (1)

  • infectious complication

    30 days

Study Arms (2)

placebo

PLACEBO COMPARATOR

no antibiotic is used

Drug: placebo

drug

ACTIVE COMPARATOR

cefazolin Sodium 1g i.v. before the operation

Drug: cefazolin Sodium

Interventions

cefazolin SodiumDRUG

cefazolin Sodium 1g i.v. before operation

drug
placeboDRUG

placebo

placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 18 years of age
  • Have solid tumor
  • White cells \>4000
  • Platelets \>100.000
  • Prothrombin time in normal range

You may not qualify if:

  • Drug allergy
  • Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Institute of Oncology

Istanbul, Capa, 34190, Turkey (Türkiye)

Location

Related Publications (1)

  • Karanlik 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: 21601826DERIVED

MeSH Terms

Conditions

Infections

Interventions

Cefazolin

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Hasan Karanlik, MD

    Istanbul University Institute of Oncology Department of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 20, 2009

First Posted

March 23, 2009

Study Start

September 1, 2008

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

June 2, 2010

Record last verified: 2009-03

Locations

TU(1)