Highlights
- •We present a pilot randomized controlled trial to evaluate a novel Foley catheter.
- •Novel silver catheter system includes an antimicrobial matrix and antireflux valve.
- •Test system was tolerated and seemingly effective in preventing bacteriuria.
- •Test system seemed especially effective against gram-negative bacilli.
- •A pivotal study is warranted.
Background
The purpose of this study was to evaluate the safety of a novel silver-impregnated
Foley catheter system designed to prevent catheter-associated bacteriuria and funguria,
assess recruitment feasibility for a future pivotal trial, and preliminarily assess
efficacy.
Methods
This single-center, randomized controlled trial at a university hospital involved
adult neurosurgical patients expected to have a urinary catheter for ≥24 hours. Subjects
were randomized to a novel silver-impregnated (test) Foley catheter system or a control
system. They were followed for 30 days (or until discharge) while catheterized and
for up to 48 hours after catheter removal, with daily bacteriuria testing and assessment
for symptoms of infection and catheter intolerance.
Results
Ninety-five subjects were randomized (intention-to-treat [ITT] population). Of these,
61 subjects (64%) had a catheter for ≥24 hours without perioperative antibiotics beyond
24 hours (evaluable population). In the ITT population, 11 of 95 (12%) subjects had
an asymptomatic bacteriuria (ABU) event. Compared with controls, test system recipients
had a trend toward longer time to ABU in the ITT population (P = .08, log-rank test) and a longer time to ABU in the evaluable population (P = .03). All 6 ABU events caused by gram-negative bacilli occurred in the control
group.
Conclusion
In this pilot randomized trial the test system was well tolerated and seemingly effective
in preventing catheter-associated bacteriuria, especially with gram-negative bacilli.
A pivotal study is warranted.
Key Words
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References
- Are physicians aware of which of their patients have indwelling urinary catheters?.Am J Med. 2000; 109: 476-480
- A decade of prevalence surveys in a tertiary-care center: trends in nosocomial infection rates, device utilization, and patient acuity.Infect Control Hosp Epidemiol. 1999; 20: 543-548
- Urinary tract etiology of bloodstream infections in hospitalized patients.J Infect Dis. 1983; 148: 57-62
- Catheter-associated urinary tract infection is rarely symptomatic: a prospective study of 1,497 catheterized patients.Arch Intern Med. 2000; 160: 678-682
- Clinical and economic consequences of nosocomial catheter-related bacteriuria.Am J Infect Control. 2000; 28: 68-75
- Engineering out the risk for infection with urinary catheters.Emerg Infect Dis. 2001; 7: 342-347
- Bacteriuria in the catheterized patient. What quantitative level of bacteriuria is relevant?.N Engl J Med. 1984; 311: 560-564
Scott RD II. The direct medical costs of healthcare-associated infections in U.S. hospitals and the benefits of prevention. 2009. Available from: http://www.cdc.gov/hai/pdfs/hai/scott_costpaper.pdf. Accessed December 1, 2014.
- Selected aspects of the socioeconomic impact of nosocomial infections: morbidity, mortality, cost, and prevention.Infect Control Hosp Epidemiol. 1996; 17: 552-557
- Inappropriate treatment of catheter-associated asymptomatic bacteriuria in a tertiary care hospital.Clin Infect Dis. 2009; 48: 1182-1188
- Management of catheter-associated urinary tract infection.Curr Opin Infect Dis. 2010; 23: 76-82
- Catheter-associated urinary tract infection and the Medicare rule changes.Ann Intern Med. 2009; 150: 877-884
- Strategies to prevent catheter-associated urinary tract infections in acute care hospitals.Infect Control Hosp Epidemiol. 2008; 29: S41-S50
- A prospective study of pathogenesis of catheter-associated urinary tract infections.Mayo Clin Proc. 1999; 74: 131-136
- Nosocomial urinary tract infection.in: Mayhall C.G. Hospital epidemiology and infection control. Lippincott Williams and Wilkins, Baltimore [MD]1996: 139-153
- Catheter-associated urinary tract infections: epidemiology, pathogenesis, and prevention.Am J Med. 1991; 91: 65S-71S
- The increasing use of silver-based products as antimicrobial agents: a useful development or a cause for concern?.J Antimicrob Chemother. 2007; 59: 587-590
- Candida species: current epidemiology, pathogenicity, biofilm formation, natural antifungal products and new therapeutic options.J Med Microbiol. 2013; 62: 10-24
- Antimicrobial urinary catheters: a systematic review.Expert Rev Med Devices. 2008; 5: 495-506
- Systematic review: antimicrobial urinary catheters to prevent catheter-associated urinary tract infection in hospitalized patients.Ann Intern Med. 2006; 144: 116-126
- A prospective trial of a novel, silicone-based, silver-coated foley catheter for the prevention of nosocomial urinary tract infections.Infect Control Hosp Epidemiol. 2006; 27: 38-43
- Antimicrobial catheters for reduction of symptomatic urinary tract infection in adults requiring short-term catheterisation in hospital: a multicentre randomised controlled trial.Lancet. 2012; 380: 1927-1935
- Multicenter cohort study to Assess the impact of a Silver-Alloy and hydrogel-coated urinary catheter on symptomatic catheter-associated urinary tract infections.J Wound Ostomy Continence Nurs. 2014; 41: 473-480
- A comparative multicentre study on the incidence of catheter-associated urinary tract infection between nitrofurazone-coated and silicone catheters.Int J Antimicrob Agents. 2004; 24: S65-S69
- Feasibility of audit and feedback to reduce postoperative urinary catheter duration.J Hosp Med. 2011; 6: 183-189
- In vitro comparison of nitrofurazone- and silver alloy-coated foley catheters for contact-dependent and diffusible inhibition of urinary tract infection-associated microorganisms.Antimicrobial Agents Chemother. 2012; 56: 4969-4972
- A novel silver-hydrogel impregnated indwelling catheter reduces CAUTIs: a prospective double-blind trial (abstract).Infect Control Hosp Epidemiol. 1998; 19: 680
- Antimicrobial activities of silver dressings: an in vitro comparison.J Med Microbiol. 2006; 55: 59-63
- Urinary tract infections in the elderly.Br J Urol. 1998; 82: 79-84
Article info
Footnotes
Funding/support: This pilot study was supported by a small business innovation research grant awarded to ICET Inc by the National Institute of Diabetes and Digestive and Kidney Diseases (no. R44 DK55891-06). Leuck is supported by a National Institutes of Health Ruth L. Kirschstein National Research Service Award Institutional Research Training Grant (no. 5T32AI055433-09). This material is also based in part on work supported by the Department of Veterans Affairs (Johnson, no. 1 I01 CX000192 01).
Conflicts of interest: Leuck, Kline, Dhody, Kazempour, and Ferrieri report no conflicts of interest. Johnson reports that he has been a paid independent consultant to ICET (the manufacturer of the test study catheter) and also has received research grants or contracts from Rochester Medical, Merck, Crucell, and Syntiron. Hunt consults on education projects for DePuy Synthes.
Additional information: This trial was registered with ClinicalTrials.gov (identification no. NCT01681511) and can be found at http://www.clinicaltrials.gov.
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© 2015 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.
