Safety and Efficacy Study of Angiotech Central Venous Catheter to Prevent Bacterial Catheter Colonization

This study has been completed.

First Received: February 6, 2006 Last Updated: July 13, 2007 History of Changes

Sponsored by:	Angiotech Pharmaceuticals
Information provided by:	Angiotech Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00288418

Purpose

The main purpose of this study is to determine if the Angiotech central venous catheter (CVC) is equal in effectiveness to a CVC coated with chlorhexidine and silver sulfadiazine in preventing bacterial catheter colonization. Other objectives of this study are to determine if the Angiotech CVC is equal in effectiveness to a CVC coated with chlorhexidine and silver sulfadiazine in preventing catheter-related local infection, and catheter-related bloodstream infection. This study will also assess the safety of the Angiotech CVC.

Condition	Intervention	Phase
Bacterial Infections	Device: Central Venous Catheter	Phase III

MedlinePlus related topics: Bacterial Infections

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Controlled, Randomized, Single-Blind, Multi-Center Pivotal Clinical Study Using Angiotech CVC to Prevent Bacterial Colonization on Short-Term Central Venous Catheters

Further study details as provided by Angiotech Pharmaceuticals:

Primary Outcome Measures:

Incidence of catheter colonization

Estimated Enrollment:	850
Study Start Date:	December 2005
Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

at least 18 years of age
Be initially hospitalized in an intensive care setting
Require insertion of a triple-lumen central venous catheter for an anticipated period of up to 28 days
If female and of child-bearing potential, provide evidence of a negative pregnancy test

Exclusion Criteria:

Has a life expectancy of less than one month
Is pregnant
Has a history of anaphylactic reactions, including reactions to contrast dyes
Has a history of allergy to 5-fluorouracil (5-FU) or chlorhexidine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288418

Show 21 Study Locations

Sponsors and Collaborators

Angiotech Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	011-ACVC05
Study First Received:	February 6, 2006
Last Updated:	July 13, 2007
ClinicalTrials.gov Identifier:	NCT00288418 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Angiotech Pharmaceuticals:

Colonization of the catheter
Catheter related bloodstream infection

Study placed in the following topic categories:

Bacterial Infections

Additional relevant MeSH terms:

Bacterial Infections
Infection

ClinicalTrials.gov processed this record on May 07, 2009