A Novel Antiseptic-Microbial Barrier Cap for CVC Hubs or Injection Ports for Prevention of CVC-Related BSI

Abstract

BACKGROUND: Patients with CVCs are at continuous risk of BSI caused by microorganisms that gain access through the hub or an injection port, particularly patients with long-term IVDs where infectious organisms most often gain access intraluminally. OBJECTIVE: We report a simulation study of a novel antiseptic cap (Saralex), which when threaded onto a luer-adaptable needleless injection port allows a chlorhexidine-impregnated sponge to come into continuous contact with the membranous surface of the port. Upon removal, there is no need to swab the membrane before accessing it with a needle or needleless connector. METHODS: One hundred five needleless IV systems of three types were tested. All contain a membrane and are accessible by a luer lock mechanism. Each test port was first heavily contaminated by dipping in a suspension of > 106 CFU/mL Enterococcus faecilis, then allowing it to dry. After 24 hours, 60 contaminated ports had the antiseptic cap threaded onto the port, removing it after 10 minutes; 30 ports were disinfected conventionally with a 70% isopropyl alcohol pledgett; and 15 were contaminated but not disinfected (positive control), before access. The contaminated test ports were then accessed with a sterile syringe containing 3mL of TSB and flushed; the flush solution was captured and cultured quantitatively. RESULTS: All 15 (100%) control ports which were not disinfected before entering showed massive microbial transmission across the membrane (4,500–10,000 CFU). Of the 30 ports accessed after conventional disinfection with an alcohol pledgett, 20 (67%) showed entry of microorganisms (442–25,000 CFU). In contrast, of 60 contaminated ports entered after application of the novel antiseptic cap for 10 minutes, only 1 (1.6%) showed any microbial transmission (P<0.001). CONCLUSIONS: This study shows that if the membranous septum of a needleless port is heavily contaminated, conventional disinfection with alcohol may not reliably prevent ingress of microorganisms and CVC–related BSI. In contrast, the antiseptic cap provides a high level of protection, even in the presence of heavy contamination. This novel technology deserves to be studied in a large multi-center clinical trial.