Rochester Medical® Corporation has pioneered the use of nitrofurazone for controlled release from silicone urological devices and manufactures a range of anti-infection silicone Foley catheters under the brand name ReleaseNF®.

ReleaseNF is the only Foley catheter to provide site-specific availabilty of an anti-infective agent into the aqueous environment of the urethral tract when inserted. ReleaseNF is designed to elute nitrofurazone over a period of time to provide site-specific prophylaxis against catheter-associated urinary tract infection.

ReleaseNF Anti-Infection Foley catheter has been reviewed by the Rapid Review Panel of the UK Health Protection Agency and received Recommendation Level 2.

Catheter-associated urinary tract infections (CAUTIs) comprise a large reservoir of infectious organisms, including antibiotic-resistant, nosocomial pathogens. They are a major cause of bacteraemia and are associated with increased catheter patient mortality. CAUTIs cost the NHS £124 million every year. Rochester Medical’s anti-infection technology provides health care professionals with an important tool to help reduce the incidence of CAUTIs.

ReleaseNF is available in the UK as a 2-Way Foley Catheter in balloon sizes 10ml and 30ml:

NITROFURAZONE

Nitrofurazone is a nitrofuran derivative similar to the urinary anti-infective nitrofurantoin that has been used for treating urinary tract infections worldwide for over 50 years. It is a safe, effective, synthetic, anti-microbial agent with a broad spectrum, including most gram-positive bacteria and facultative gram-negative bacilli. Antimicrobial activity remains effective in the presence of blood, serum or tissue.

Acquired resistance of bacteria to nitrofurans during therapy has not appeared on a significant scale in over 60 years of use. The most likely reason for lack of acquired resistance is the multiple mechanisms of action against bacteria.

Nitrofurazone is non-systemic when used in a topical application. Tests have shown no detectable blood levels of nitrofurazone after 12 hours, 24 hours, 7 days and 14 days of catheterisation*.

DOWNLOAD PDF of Test Data

Adverse events related to nitrofurans are very rare, with a low incidence of sensitisation.

ACTIVITY AGAINST PATHOGENS

ReleaseNF shows excellent in-vitro activity against multi-drug resistant uropathogens (MDR), including resistant strains of E. coli and MRSA.

In-vitro studies have shown that segments of ReleaseNF Foley catheters inhibit a wide range of bacterial pathogens that are commonly associated with urinary tract infections.

CLINICAL STUDIES

Clinical studies confirm that ReleaseNF reduces the incidence of catheter-associated bacteriuria compared to a control, standard silicone Foley catheter.

A randomised, controlled clinical study with 344 patients showed a 10-fold reduction in bacterial catheter-associated urinary tract infection after 3 days and a 6-fold reduction at 5 days. There were no reports of adverse reactions during the study. (Maki & Holcomb 1997)

Maki & Holcomb (1997)

A further, randomised, controlled, clinical study with 154 trauma patients also confirmed a proven reduction in catheter-associated urinary tract infection and demonstrated over a 3-fold reduction in the need to treat catheter-associated urinary tract infection. (Stensballe et al 2007)

http://www.annals.org/cgi/content/abstract/147/5/285

To receive a copy of the full publication please email your contact details to: ukcustomercare@rocm.com

DOWNLOAD A PDF OF A report on the randomised, controlled clinical trial of the nitrofurazone-impregnated, antibacterial, indwelling foley catheter. Maki & Holcomb (1997)

DOWNLOAD A PDF OF Effect of a Nitrofurazone-Impregnated Urinary Catheter on the Incidence of Catheter-Associated Urinary Tract Infection in Burn Patients. LeClair et al (2000)

DOWNLOAD A PDF OF Anti-Infection Technology Bibliography

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