Novel Device for Reducing Catheter-Related Infections
Not Applicable
Withdrawn
- Conditions
- Intensive Care
- Interventions
- Device: silicone catheter boot
- Registration Number
- NCT00878683
- Lead Sponsor
- University of Kansas
- Brief Summary
This study is a pilot study of the safety, tolerability and efficacy of an investigational central venous catheter device used in conjunction with a standard central venous catheter. The hypothesis is that utilization of a catheter device incorporating cyanoacrylate will reduce catheter colonization by bacteria, and may decrease the rate of catheter-related bloodstream infections.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Admission in the ICU at time of catheter insertion
- Indication for central venous catheter placement
- De novo catheter insertion in the subclavian or internal jugular veins
Exclusion Criteria
- Anticipated catheter duration < 72 hours
- Planned guidewire exchange
- Documented bacteremia within 48 hours prior to catheter placement
- Extensive skin breakdown near the site of potential catheter placement
- Emergent line placement
- Screening labs with ANC < 500 or platelets < 50K
- Hypersensitivity to cyanoacrylates or formaldehyde
- Prior enrollment in study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 silicone catheter boot Device and standard catheter
- Primary Outcome Measures
Name Time Method Catheter site inspection Baseline, Daily
- Secondary Outcome Measures
Name Time Method