Evaluation of central venous catheters coated with a noble metal alloy—A randomized clinical pilot study of coating durability, performance and tolerability

Abstract

The use of Central Venous Catheters (CVCs) commonly results in complications. Coatings with silver or metal alloys can reduce the risk associated with the use of CVC. We have evaluated the durability of a noble metal coated CVC (the Bactiguard Infectious Protection, BIP CVC) and compared with an uncoated CVC for clinical tolerability (Adverse Events, AEs) and performance, in order to create a baseline for a large future study. Patients undergoing major surgery, randomised at a 2:1 ratio to BIP CVC (n = 22) or standard CVC (n = 12), were catheterized 9 ‐ 12 days, respectively. Adverse events, microbial colonization and metal release were measured. Findings: There were no AEs in the BIP CVC‐group, but 5 AEs occurred in 4 patients (1 patient had 2 AEs) in the standard CVC‐group, p = 0.011 (whereof 3 were catheter related). The BIP CVC showed an initial release of coating metals in blood (gold, silver and palladium), which rapidly decreased and were far below Permitted Paily Exposure (PDE) for chronical use. The levels of silver concentration were far below those needed to develop microbial resistance. The performance was equal, and there was no difference concerning microbial colonization, for the two CVCs. Conclusion: In this pilot study the BIP CVC had significantly lower AEs and showed a comparable performance to the standard CVC. The coating was durable throughout the study length (up to 16 days) and toxicological evaluation showed good safety margins. Larger studies are needed. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 2337–2344, 2018.

A Novel Device-Integrated Drug Delivery System for Local Inhibition of Urinary Tract Infection

“…Surprisingly, however, some pigs in the BIP-C group were found to partly clear the infection over time, as bacteriuria was significantly reduced in the urine samples at 48 hpi, thus demonstrating that the antibacterial effects of the BIP-C are not exclusive to the catheter surface but actively suppress the UPEC population inside the bladder lumen as well. This may be a result of metal-ion leakage, particularly silver, which previously has been reported to be released in small amounts from a similar coating used in Bactiguard Infection Protection central venous catheters in human patients (Björling et al, 2018).…”

“…Using the catheter balloon lumen for drug storage essentially provides an unlimited reservoir capacity. While drug coatings on antimicrobial catheters degenerate over time and often fail to significantly reduce the risk of CAUTI, drugs administered over the balloon wall retains the same daily release rate and can be replenished if needed, without the need of replacing the catheter (Pickard et al, 2012a,b;Björling et al, 2018).…”

“…The BIP-C, which is validated in clinical trials and so far sold in over 200 million copies, was used as a benchmark test (Lederer et al, 2014). The technology behind the antiinfective effects of the BIP catheter is based on an alloy coating of gold, silver, and palladium that, upon contact with fluids, produces a galvanic reaction that repels bacteria and thus prevents their attachment to the catheter surface (Björling et al, 2018). Indeed, adherent bacteria were significantly reduced in BIP-C compared to that in control, but BIP-C failed to prevent the experimental infection in this model, as all pigs in the BIP-C group developed significant bacteriuria (>10 5 CFU ml −1 ) 24 h postinfection (hpi).…”

Preparation of anti-bacterial biocomposite nanofibers fabricated by electrospinning method

“…The addition of Ag + ions into polymeric materials has been used extensively for several years. Ag + layer decreased infections especially in urinary and venous catheters (40)(41)(42). In addition, the antibacterial property can be obtained from natural materials.…”

Systematic Comparison of Epidemic and Non-Epidemic Carbapenem Resistant Klebsiella pneumoniae Strains

“…Namely, these include early recognition of both carriers and infected patients ( Borer et al, 2012 ; Gorrie et al, 2017 ; Liu et al, 2019 ), and controlling the spread of pathogens with apparently still effective hand hygiene and disinfection of inanimate surfaces ( Kramer et al, 2006 ; Borer et al, 2012 ; Gorrie et al, 2017 ). Multiple studies also focus on novel approaches to prevent infections by coating endotracheal tubes and catheters with new antibacterial agents ( Caratto et al, 2017 ; Bjorling et al, 2018 ; Seitz et al, 2019 ). Such multifrontal measures to control K. pneumoniae is likely to be necessary for tempering both epidemic and non-epidemic strains.…”