A recently published clinical study* conducted at the Karolinska University Hospital in Sweden shows that Bactiguard’s infection prevention central venous catheter – BIP CVC had significantly fewer adverse events compared to a standard uncoated CVC. The study also shows that Bactiguard’s noble metal alloy does not expose patients or the environment to any risks in blood applications.
“This study confirms that the Bactiguard coating is durable and safe for patients also in blood applications and it shows promising results when it comes to reducing device related complications such as sepsis and thrombosis”, says Gunilla Björling, PhD and researcher at the Swedish Red Cross University College and Karolinska Institute, who is the first author of the publication.
The study was conducted on patients undergoing major abdominal surgery. 34 patients were randomized in two groups, 12 patients received standard CVCs and 22 patients received Bactiguard CVCs. When comparing the outcome, no adverse events were reported in the Bactiguard group, while five adverse events (of which 3 catheter-related) were reported in the control group.
The study also analyzed the amount of noble metals in patient blood and on the catheters after use of BIP CVC. The concentration in blood was far below permitted daily exposure (PDE) for chronic use and far below those required to develop microbial resistance. The noble metal levels on the catheters after use showed that the coating is durable in blood during entire usage time. The study is published in Journal of Biomedical Materials Research and is available on PubMed.
*Björling G, Johansson D, Bergström L, Strekalovsky A, Sanchez J. Evaluation of central venous catheters coated with a noble metal alloy—A randomized clinical pilot study of coating durability, performance and tolerability. Journal of Biomedical Materials ResearchB: Applied Biomaterials
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