Product Evaluation of Silver/Hydrogel-Coated Silicon Foley Catheters: An
examination of the efficacy, cost-effectiveness and catheter-associated
nosocomial urinary tract infections contracted over a 14-month period
PI: Trish M. Perl, MD, MSc
Sponsor: Bard Medical Divison, CR Bard, Inc.
Urinary tract infections (UTIs) are the most common nosocomial infection in
both acute and long-term care healthcare facilities, accounting for 34.5% of
all reported nosocomial infections. Over five million patients require a
urinary catheter each year and it is estimated that 15% to 50% develop
catheter-associated nosocomial UTIs (CANUTIs). UTIs are predominately a
device-associated infection with over 80% associated with indwelling urinary
(Foley) catheters. Furthermore, the risk of development of an UTI increases
with increasing duration of catheterization. Nosocomial UTIs result in
secondary blood stream infections (BSI) in 1% to 4% of patients.
A variety of techniques have been shown to be effective in preventing urinary
tract infection among catheterized, acute and long-term care patients. These
include: aseptic technique at insertion, closed drainage systems, limiting
the duration of catheterization and the use of silver ion impregnated
catheters. Silver-alloy/hydrogel coated catheters (Bardex I.C.) have been
shown to prevent adherence of bacteria in in vitro studies and have not been
associated with antimicrobial resistance to date. Silver ions have been shown
to inhibit both gram-positive and gram-negative bacteria and have been shown
to be effective against Enterococcus, coagulase-negative Staphylococcus and Candida.
The primary objective of this study is to determine whether using Silver/Hydrogel-Coated
Silicon Foley Catheters (SHCSF catheters) reduces catheter-associated
nosocomial urinary tract infections (CANUTIs) when compared to Silicon
Foley Catheters (uncoated catheters). The secondary objectives include:
(1) determing if there is a difference in the number of catheter days
patients remain CANUTI-free by catheter, (2) determing if a reduction in
bacteremia and candidemia secondary to UTIs occurs with SHCSF catheters,
(3) performing a cost-benefit analysis of the device taking into account
cost of the catheter, length of stay and additional costs incurred for CANUTI
patients, and (4) testing computer-based CANUTI detection.
For more information on this study please email Ann Richards
or contact her at (443) 287-4570.
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