Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device

NCT ID: NCT00867295

Last Updated: 2010-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo

no antibiotic is used

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

drug

cefazolin Sodium 1g i.v. before the operation

Group Type ACTIVE_COMPARATOR

cefazolin Sodium

Intervention Type DRUG

cefazolin Sodium 1g i.v. before operation

Interventions

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cefazolin Sodium

cefazolin Sodium 1g i.v. before operation

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Istanbul University Institute of Oncology

Principal Investigators

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Hasan Karanlik, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University Institute of Oncology Department of Surgery

Locations

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Istanbul University Institute of Oncology

Istanbul, Capa, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 21601826 (View on PubMed)

Other Identifiers

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2009/22

Identifier Type: -

Identifier Source: org_study_id

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