Foley catheter with noble metal alloy coating for preventing catheter-associated urinary tract infections: a large, multi-center clinical trial

Abstract

Background Catheter-associated urinary tract infections (CAUTI) are among the most frequent healthcare-associated infections in the world. They are associated with increased mortality, prolonged hospital stay and increased healthcare costs. The objective of this study was to evaluate the efficacy of the noble metal alloy (NMA) coated BIP Foley Catheter in preventing the incidence of symptomatic CAUTI in a large cohort of patients in India. Methods This multi-center, prospective study included 1000 adult patients admitted to six hospitals across India for urology, surgery and ICU requiring urethral catheterization and admission for ≥ 48 h. Patients were allocated to the NMA-coated BIP Foley Catheter group or a non-coated control catheter group, with a randomization ratio of 3:1. CAUTI surveillance was conducted at study entry, upon catheter removal, and 2 days after catheter removal. For statistical analysis, categorical data (e.g. gender) were compared using the chi-square or Fischer test, and numerical data were compared using the two-sample t-test. Associations were evaluated using logistic regression. Results and conclusions The incidence of symptomatic CAUTI was reduced by 69% in the BIP Foley Catheter group compared to the control group (6.5 vs 20.8 CAUTI/1000 catheter days), with an incidence rate ratio of 0.31 (95% confidence interval: 0.21–0.46; p < 0.001). A reduction in the cumulative CAUTI incidence was evident in the BIP Foley Catheter group within 3 days after catheterization; this reduction was maintained up to ~ 30 days, and the largest reductions were seen between 3 and 11 days. There were no serious adverse events related to either catheter, and the percentage of patients with ≥ 1 adverse event was significantly lower in the NMA-coated BIP Foley Catheter group than in the control group (21.6% vs. 48.4%; p = 0.001). In conclusion, the NMA-coated BIP Foley Catheter was effective in reducing CAUTI and was well tolerated, with a lower incidence of adverse events compared to the uncoated catheter. Trial registration This study was registered prospectively (28 September 2015) in the Clinical Trials Registry of India (trial number CTRI/2015/09/006220; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=12631&EncHid=&userName=bactiguard).

Facile Modification of Medical-Grade Silicone for Antimicrobial Effectiveness and Biocompatibility: A Potential Therapeutic Strategy against Bacterial Biofilms

“…An interesting study reported leaching of metals into urine was minimal or undetectable . In one urine sample, 0.2 μg/L silver was detected, which is 4% of the permitted daily exposure for drugs …”

“…However, the CAUTI risk was lower in the coated group among patients requiring catheterization for longer than 14 days . A coating comprised a palladium, gold, and silver alloy layer and a hydrogel outer layer significantly decreases the incidence of CAUTI . An interesting study reported leaching of metals into urine was minimal or undetectable .…”

“…69 A coating comprised a palladium, gold, and silver alloy layer and a hydrogel outer layer significantly decreases the incidence of CAUTI. 70 An interesting study reported leaching of metals into urine was minimal or undetectable. 71 In one urine sample, 0.2 μg/L silver was detected, which is 4% of the permitted daily exposure for drugs.…”

“…71 In one urine sample, 0.2 μg/L silver was detected, which is 4% of the permitted daily exposure for drugs. 70 In response to pathologies that include acute hydrocephalus and traumatic brain injury, external ventricular drains (EVDs) are put in place for patients with elevated intracranial pressure. The rifampin-clindamycin antibiotic combination incorporated into Bactiseal EVD is aimed at inhibiting Gm+ bacterial colonization.…”

Prevention of ventilator-associated pneumonia by noble metal coating of endotracheal tubes: a multi-center, randomized, double-blind study

“…The galvanic effect of noble metal alloys creates a microcurrent that reduces the formation of bacterial biofilm, and thus colonization of the ETTs, and subsequent respiratory infection [ 12 ]. Metal-coated urinary catheters have been on the market since 1995 and have been tested in a large number of clinical studies; results have demonstrated a reduction in urinary tract infections and antibiotic use [ 13 – 18 ]. Although there is substantial clinical evidence demonstrating that the NMA coating can reduce the infection rate related to other medical devices such as urinary catheters, more data on the efficacy of NMA-coated ETTs on VAP are needed.…”