Novel Device for Reducing Catheter-Related Infections

Exploring the Use of a Novel Device for Reducing Catheter-Related Bloodstream Infections

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00878683

Enrollment

Registered

2009-04-09

Start date

2009-07-31

Completion date

2011-04-30

Last updated

2015-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care

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.

Interventions

DEVICEsilicone catheter boot

silicone device using Dermabond

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Catheter site inspection	Baseline, Daily

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026