Effectiveness of Antibiotic Prophylaxis for Totally Impla... | NCT00867295

Studies
Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device

NCT00867295

Sponsor

Istanbul University

Status

Completed

Last Update Posted

Jun 2, 2010Estimated

Enrollment

150Estimated

Phase

Phase 3

Conditions

Solid Tumor

Interventions

cefazolin Sodium
placebo

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Mar 2010Actual

First Submitted Date

Mar 20, 2009

First Submission Date that Met QC Criteria

Mar 20, 2009

First Posted Date

Mar 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2010

Last Update Posted Date

Jun 2, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo	Placebo Comparator	no antibiotic is used	Drug: placebo
drug	Active Comparator	cefazolin Sodium 1g i.v. before the operation	Drug: cefazolin Sodium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cefazolin Sodium	Drug	cefazolin Sodium 1g i.v. before operation	drug

Measure	Description	Time Frame
infectious complication		30 days

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hasan Karanlik, MD	Istanbul University Institute of Oncology Department of Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul University Institute of Oncology		Istanbul	Capa	34190	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21601826	Derived	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.

ID	Term
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930