Clinical evidence

A majority of healthcare associated infections are commonly caused by medical devices, and occur in three main areas of the body: the urinary tract, the respiratory tract and the bloodstream. Bacterial adhesion to medical devices is an essential step in the development of infective biofilm, causing devi­ce related infections, increased use of antibiotics and bacterial resistance. The Bactiguard coating has been proven to reduce bacterial adhesion and colonization on the device surface thereby li­miting the formation of biofilm and significantly reducing the risk of infection.  

Since there is no toxic release of substances – the surface is also proven to be tissue friendly with no coating related adverse events reported on 150 million products used to date. The technology is furthermore non-thrombogenic and does not trigger immune reactions.

Bactiguard-coated products have been used in a large number of clinical studies and evalu­ations (1986–2015) involving over 100,000 patients. The purpose has been to assess the technology´s efficacy in preventing infections as well as its safety and performance . In addition, Bactiguard in vitro assays have demonstrated a reduction of microbial adhesion to Bactiguard-coated products by at least 70-90% compared to non-coated.

Urinary tract

Catheter Associated Urinary Tract Infection (CAUTI) is the most common out of healthcare associated infections (HAI), with 32% of all HAI´s10

Detailed evaluation of data in peer-reviewed publications for patients catheterized for >2 days reveals that symptomatic urinary tract infections are reduced by on average 35%1,2,3,4,5,6, and even over 70% in some studies4. One of these recent publications has also shown a 60% lower use of antibiotics in the Bactiguard group compared to the standard catheter group2. Minimizing the overuse of antibiotics is an important step in preventing the spread of resistant bacteria.

Blood stream

Catheter related bloodstream infections (CBRSI), also known as Central Line Associated Bloodstream Infections (CLABSI), account for 14% of healthcare associated infections (HAI) in patients using medical devices, such as central venous catheters (CVC)10.

A larger randomized clinical study including Bactiguard coated central venous catheters shows a significant reduction in the number of blood stream infections (CRBSI/CLABSI) with 52% after 13 days of catheterization, compared to a standard non-coated catheter7.  In the same study, Bactiguards coating has been proven to have good biocompatibility profile in blood. There is no increased risk for adverse events such as thrombosis, when using the Bactiguard coated product8.


 

In ex-vivo experiment with human blood, BIP CVC has shown significantly lower hemolytic activity compared to also the most commonly used coated central venous catheter. BIP CVC shows low activation of coagulation and complement systems, as well as significantly lower activation of coagulation compared to uncoated catheters9.

Respiratory tract

Infections of the respiratory tract are serious, and as common as, 15% out of healthcare associated infections (HAI) that afflict patients using certain medical devices, such as endotracheal tubes (ET tube or ETT)10.

At the congress Euroanasthesia 2015 a poster was presented describing that the coating of Bactiguard´s endotracheal tube BIP ETT reduced the incidence of ventilator associated pneumonia by 67% (OR 3.42; p=0.14) in a study on 100 patients performed in ICU setting11.

Bone applications

Some initial studies have been performed to assess the impact on bone integration for implants coated with the Bactiguard noble metal alloy. A published animal study showed at least as good osseointegration properties of a Bactiguard coated titanium screw in rabbit after 12 weeks of implantation, compared to a non-coated titanium screw12

1. Hidalgo Fabrellas et al, Enferm Intensiva 2015; 26(2):54-62
2. Pickard et al, The Lancet, Nov 5, 2012
3. Lederer JW et al, J WOCN 2014; 41(5):1-8
4. Seymour C et al, British Journal of Nursing, 2006; 15(11): 598-603
5. Gentry H et al, Nursing Standard. 2005; 19, 50, 51-54
6. NewtonT et al, Infection Control and Hospital Epidemiology; 2002; 23(1): 217-8
7. Goldschmidt H.et al., Zbl. Bakt.1995; 233: 215-223
8. Harter et al, Cancer. 94 (1):245-251 (2002)
9. Vafa Homann et al,  J Biomed Mater Res Part B 2015; DOI: 10.1002/jbm.b.33403
10. Klevens RM et al, Public Health Rep. 2007 Mar-Apr;1222):160-6
11. Tincu R et al, Poster Euroanasthesia 2015
12. Svensson S, et al, Nanomedicine. 2013 Oct;9(7):1048-56