Novel Device for Reducing Catheter-Related Infections

• Sponsor: University of Kansas (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00878683
• Collaborator: University of Missouri-Columbia (Other)
• Enrollment: 0
• Arms: 2
• Duration (Months): 21

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intensive Care	Device: silicone catheter boot	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Exploring the Use of a Novel Device for Reducing Catheter-Related Bloodstream Infections
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Device and standard catheter	Device: silicone catheter boot; silicone device using Dermabond
No Intervention: 2 Standard catheter

Outcome Measures

Primary Outcome Measures

1. Catheter site inspection [Baseline, Daily]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Kansas
• University of Missouri-Columbia

Investigators

• Principal Investigator: Stephen Waller, MD, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00878683
• Other Study ID Numbers: 11525
• First Posted: Apr 9, 2009
• Last Update Posted: May 5, 2015
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Infections

Study Results

No Results Posted as of May 5, 2015