Novel Device for Reducing Catheter-Related Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Intensive Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Device and standard catheter

Group Type EXPERIMENTAL

silicone catheter boot

Intervention Type DEVICE

silicone device using Dermabond

2

Standard catheter

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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silicone catheter boot

silicone device using Dermabond

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No