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
1 other identifier
interventional
960
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2005
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 6, 2006
CompletedFirst Posted
Study publicly available on registry
February 8, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedJanuary 23, 2013
January 1, 2013
1.6 years
February 6, 2006
January 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of catheter colonization
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.
Maximum of 28 days
Study Arms (2)
ARROWgard Blue® CVC
ACTIVE COMPARATOR7-French x 20-cm, triple lumen, short-term CVC
Angiotech CVC
EXPERIMENTALA 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
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
St Vincent Mercy Medical Center, Bldg 1
Toledo, Ohio, 43608, United States
Medical University of Ohio
Toledo, Ohio, 43614, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Heard, MD
University of Mass. Medical School Department of Anesthesiology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 6, 2006
First Posted
February 8, 2006
Study Start
December 1, 2005
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
January 23, 2013
Record last verified: 2013-01