Beneficiary: Rostock University Medical Center 
Funding exploratory phase: 01.04.2011 - 31.12.2011; 54,966 Euro
Funding feasibility phase: 01.01.2012 – 31.08.2014; 491,804 Euro

Project Description

The use of central venous catheters (CVC) often leads to severe infections caused by contaminated CVC. Every year, catheter sepsis causes 24,000 deaths in 160,000 bloodstream infections (BSI) in the EU. For the USA, 28,000 deaths in 71,900-90,000 cases of CLABSI (Central Line Associated Bloodstream Infection) have been cited. The mortality rate after surviving CLABSI remains significantly higher in the following years. The additional costs for extended treatment of CLABSI amount to at least €1 billion annually for Germany and US$4.1 billion for the USA with additional costs of US$46,000 per individual case. An increase in mortality due to the increase in resistance to antibiotics is to be anticipated.

The funding project, which is located at the Rostock University Medical Center, has developed a method for the prevention of sepsis associated with CVC during the exploratory and feasibility phase. The product CutSep unfolds its effect through the prevention and decontamination of CVCs of all kinds, because only a germ-free catheter is safe. An operating room it is not sterile, and humans shed 40 million germs via skin abrasion and microdroplets every hour. In addition, many bacteria in the stratum corneum are not affected by skin disinfection. These germ sources contaminate the catheters and are the basis for a biofilm that can be detected on 30% of all used CVCs.

The gel inactivates and washes off contaminants and is effective until it passes through the skin where it is wiped off. Directly in front of the catheter system, the CVC is inserted into an applicator and pulled out again, leaving behind a temporary gel film. As usual, the catheter is then rinsed and positioned using the Seldinger technique. CutSep only works outside the body and is limited to the short period during which the device is placed. The effectiveness is 99% germ reduction on catheters after skin penetration. This type of targeted prevention through product protection is new and has been patented worldwide. Now the efficiency of the method is to be demonstrated in a randomized study. If the incidence of biofilms were to be reduced by 25%, the method would have the potential to prevent several thousand deaths worldwide each year, as well as to save costs in the billions and around 48,000 disability-adjusted life years (DALY) in the EU.