Research Project
9679854
Project Summary/Abstract We propose a new approach to the decontamination of central venous catheters and the prevention of central line-associated bloodstream infections (CLABSI), an important healthcare-associated infection. CLABSIs cost the US healthcare system approximately $2.3 billion annually (Pronovost, NEJM, 2009). Additionally, CLABSIs can be life threatening, especially in the very young and critically ill. Even when treated appropriately, they can result in endocarditis, meningitis, bone and joint infections. Most centers recommend to ?scrub the hub? of a central venous catheter (CVC) for 15 seconds using a 70% isopropyl alcohol pad prior to each use (e.g. administration of an intravenous medication). In the busy workflow of an intensive care unit or hospital ward, compliance with these recommendations is inconsistent. Instead, SnapCap is a patented, disposable device that houses a compressible alcohol-soaked foam between non-circumferential female luer threads inside of a plastic housing. To decontaminate a NC, a provider engages the SnapCap threads onto the NC and turns it 5 times, each time an audible and tangible click, as well as a squeak of the NC against an alcohol-soaked sponge contained within it. This decontamination process changes the focus from the clock to the patient, is fast (~3 seconds), is easy to perform and applies ~5X the scrubbing force relative to manual scrubbing. Preliminary tests on prototypes have demonstrated equivalent reduction in bacterial load as a 15 second manual scrub. The research team from Boston Children?s Hospital has partnered with a small business concern with extensive expertise in medical device manufacturing, Contech Medical, to produce a near-final cap design. Together, we propose the following aims. Aim 1. To determine the maximum reduction (i.e. log reduction) in pathogen load from NCs contaminated with known CLABSI pathogens (including antimicrobial-resistant organisms) using the SnapCap as intended (5 snaps), compared with the current standard of care (conservatively, a 30 second alcohol scrub). Aim 2. In a series of simulated clinical scenarios, to compare the compliance with cleaning recommendations between the current standard of care and using SnapCap as intended (e.g. 5 snaps, subaim 2a), and to obtain user experience feedback with SnapCap from bedside nurses (subaim 2b). Aim 3. To complete a biological evaluation of the SnapCap device according to ISO 10993 standards, including cytotoxicity, sensitization, cutaneous sensitivity, and hemocompatibility testing. If successful, this work would demonstrate that this efficient approach to catheter decontamination is equally effective in removing the bacterial load from a CVC and improves compliance with cleaning recommendations. Due to the importance of CVC decontamination in CLABSI prevention, this device may decrease the incidence of CLABSI and reduce healthcare costs. Subsequent work would include 510k approval and manufacturing.
