Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed No phase listed Observational

Comparison of Infection Rates Among Patients Using Two Catheter Access Devices

ClinicalTrials.gov ID: NCT00965198

Public ClinicalTrials.gov record NCT00965198. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 6:33 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Comparison of a Novel Silver-Coated Catheter Access Device and a Standard Catheter Access Device: A Dual Center Cross-Over Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Intravenous catheters are placed in nearly every hospitalized patient. These catheters, since they are breaks in skin integrity, are potential sources of infection that occur in the bloodstream. Bloodstream infections can result in higher rates of death and lengths of hospital stay, as well as increase healthcare costs. Blood is drawn or medications delivered through a catheter access device attached to the catheter. In looking at new ways to decrease infections associated with healthcare, the investigators plan to test whether the use of a silver-coated catheter access device (VLINK) compared to the standard, non-coated device (CLEARLINK) can reduce infection rates. These devices are identical in design other than the silver coating of the VLINK, that imparts a brown color to the device. Silver can prevent the growth of bacteria inside the device (biofilm formation) in the laboratory, but this has never been proven in patients. The investigators propose to do a crossover study in two Emory-owned hospitals (Emory University Hospital and Emory University Hospital at Midtown), anticipated to last 10 months. Currently, both types of devices, (standard and silver-coated) are FDA approved for clinical use and are in use at both hospitals. The investigators plan to have each hospital use only one type of catheter access device for a period of time (approximately 5 months), and then switch ("crossover") to other type of device for the rest of the study. All patients admitted to either hospital (excluding newborns and patients with infections attributed to hemodialysis catheters) will be enrolled since both devices meet the standard of care. During the study, the infection prevention department, as a continuing part of their regular duties will measure infection rates. A small subset of catheters that are removed during routine clinical care (none will be taken out solely for the study) will be sent to CDC to determine the amount of bacteria inside catheters and catheter access devices (look for biofilm). Finally, the microbiology lab, again as part of its routine function will determine the rate at which blood cultures are falsely positive. All of these measures will be compared using statistical methods to see if there is a difference between the standard and silver-coated catheter access devices. In undertaking this study, the investigators will be using a type of vascular access device (valve, not positive pressure) already in use in both hospitals and not changing the delivery of care to patients while, in a rigorous, systematic manner, obtaining samples and data for analysis.

Study identification

NCT ID
NCT00965198
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Emory University
Other
Enrollment
10,000 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 31, 2009
Primary completion
Jun 30, 2011
Completion
Jun 30, 2011
Last update posted
Nov 20, 2013

2009 – 2011

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Emory University Hospital Atlanta Georgia 30033
Emory University Hospital Midtown Atlanta Georgia 30308

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00965198, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 20, 2013 · Synced Sep 6, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00965198 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →