Bacteremia Clinical Trial
Official title:
Comparison of a Novel Silver-Coated Catheter Access Device and a Standard Catheter Access Device: A Dual Center Cross-Over Study
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.
n/a
Observational Model: Case-Crossover, Time Perspective: Prospective
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