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

This study has been completed.
Sponsor:
Information provided by:
Angiotech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00288418
First received: February 6, 2006
Last updated: January 22, 2013
Last verified: January 2013
History of Changes

February 6, 2006
January 22, 2013
December 2005
July 2007   (final data collection date for primary outcome measure)
Incidence of catheter colonization [ Time Frame: Maximum of 28 days ] [ Designated as safety issue: No ]
Primary Objective: The primary objective of this study was to determine the non-inferiority of the Angiotech Central Venous Catheter (CVC) when compared to the ARROWgard Blue® CVC to prevent bacterial catheter colonization.
Incidence of catheter colonization
Complete list of historical versions of study NCT00288418 on ClinicalTrials.gov Archive Site
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Safety and Efficacy Study of Angiotech Central Venous Catheter to Prevent Bacterial Catheter Colonization
A Controlled, Randomized, Single-Blind, Multi-Center Pivotal Clinical Study Using Angiotech CVC to Prevent Bacterial Colonization on Short-Term Central Venous Catheters

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.

Central venous catheters are widely used for hemodynamic monitoring and the administration of fluids, drugs, and nutrition. The most frequent life-threatening complication of central venous catheter use is septicemia. Normal cutaneous flora may invade the intracutaneous tract during or after catheter insertion. The colonizing bacteria subsequently disseminate along the catheter surface and ultimately seed into the blood stream.

In the United States, a total of 250,000 cases of central venous catheter-related infections are estimated annually. Costs per infection are estimated as high as US$56,000. It is clinically imperative that effective measures be found to decrease catheter infection rates while minimizing the risk of the development of microbial resistance.

Primary Objective: The primary objective of this study is to determine the non-inferiority of the Angiotech Central Venous Catheter (CVC) when compared to the ARROWgard Blue® CVC to prevent bacterial catheter colonization.

Secondary Objectives: The secondary objectives of this study are to determine the non-inferiority of the Angiotech CVC when compared to the ARROWgard Blue® CVC to prevent:

  1. catheter-related local infection; and
  2. catheter-related bloodstream infection.

Safety Objectives: This study will assess the safety of the Angiotech CVC.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Bacterial Infections
Device: Central Venous Catheter
7-French x 20-cm, triple lumen, short-term CVC vs. 7-French x 20-cm, triple lumen, short-term CVC with an anti-infective polymer coating, applied to the outer surface that contains the active pharmaceutical ingredient 5-fluorouracil (5-FU). The Angiotech CVC uses a 50µg/linear cm dose of 5-FU
  • Active Comparator: ARROWgard Blue® CVC
    7-French x 20-cm, triple lumen, short-term CVC
    Intervention: Device: Central Venous Catheter
  • Experimental: Angiotech CVC
    A 7-French x 20-cm, triple lumen, short-term CVC with an anti-infective polymer coating, applied to the outer surface that contains the active pharmaceutical ingredient 5-fluorouracil (5-FU). The Angiotech CVC uses a 50µg/linear cm dose of 5-FU
    Intervention: Device: Central Venous Catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
960
July 2007
July 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00288418
011-ACVC05
No
Rui Avelar/ CMO, Angiotech
Angiotech Pharmaceuticals
Not Provided
Principal Investigator: Stephen Heard, MD University of Mass. Medical School Department of Anesthesiology
Angiotech Pharmaceuticals
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP