Novel Device for Reducing Catheter-Related Infections

Kansas Board of Regents

Status: Withdrawn

Conditions: Intensive Care

Treatments: Device: silicone catheter boot

Study type: Interventional

Funder types: Other

Identifiers

NCT00878683

11525

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

1

Experimental group

Description:

Device and standard catheter

Treatment:

Device: silicone catheter boot

2

No Intervention group

Description:

Standard catheter