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

Information source: Angiotech Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Infections

Intervention: Central Venous Catheter (Device)

Phase: Phase 3

Status: Completed

Sponsored by: Angiotech Pharmaceuticals

Official(s) and/or principal investigator(s):
Stephen Heard, MD, Principal Investigator, Affiliation: University of Mass. Medical School Department of Anesthesiology

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome: Incidence of catheter colonization

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Cardio-Thoracic Surgeons, P.C., Birmingham, Alabama 35235, United States

Pulmonary Consultant Group, Orange, California 92868, United States

Pulmonary Center Sharp Memorial Hospital, San Diego, California 92123, United States

Kaiser Permanente Santa Teresa, San Jose, California 95119, United States

Denver Health Medical Center, Denver, Colorado 80204, United States

Christiana Care Research Institute, Newark, Delaware 19713, United States

Florida Research Network, LLC, Gainesville, Florida 32605, United States

Atlanta Institute for Medical Research Inc, Decatur, Georgia 30030, United States

Kerry Thibodeaux, M.D., Opelousas, Louisiana 70570, United States

UMASS Medical School, Dept of Anesthesiology, Worcester, Massachusetts 01655, United States

Newark Beth Israel Hospital, Newark, New Jersey 07112, United States

Pulmonary and Critical Care Medicine, Cincinnati, Ohio 45267, United States

Medical University of Ohio, Toledo, Ohio 43614, United States

St Vincent Mercy Medical Center, Bldg 1, Toledo, Ohio 43608, United States

Universty of Oklahoma HSC, Oklahoma City, Oklahoma 73104, United States

Drexel University College of Medicine, Philadelphia, Pennsylvania 19102, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

Rapid City Regional Hospital, Rapid City, South Dakota 57701, United States

University of Virginia, Department of Anesthesiology, Charlottesville, Virginia 22908, United States

Winchester Medical Center, Winchester, Virginia 22601, United States

Franciscan Health System Research Center, Tacoma, Washington 98405, United States

Additional Information

Starting date: December 2005
Last updated: January 22, 2013

Page last updated: August 23, 2015

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