Bacterial Infections
Conditions
Keywords
Colonization of the catheter, Catheter related bloodstream infection
Brief summary
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.
Detailed description
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.
Interventions
DEVICECentral 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
Sponsors
Angiotech Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of catheter colonization | Maximum of 28 days | 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. |
Countries
United States
Outcome results
None listed