Novel Device for Reducing Catheter-Related Infections | NCT00878683

Studies
Novel Device for Reducing Catheter-Related Infections

NCT00878683

Sponsor

University of Kansas

Status

Withdrawn

Last Update Posted

May 5, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Intensive Care

Interventions

silicone catheter boot

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Never received IRB approval; Withdrawn before enrollment ever started

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Apr 7, 2009

First Submission Date that Met QC Criteria

Apr 8, 2009

First Posted Date

Apr 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2015

Last Update Posted Date

May 5, 2015Estimated

Name	Class
University of Missouri-Columbia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Device and standard catheter	Device: silicone catheter boot
2	No Intervention	Standard catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
silicone catheter boot	Device	silicone device using Dermabond	1

Measure	Description	Time Frame
Catheter site inspection		Baseline, Daily

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen Waller, MD	University of Kansas Medical Center	Principal Investigator

Locations

Not provided