MDS-20PUREU001 PureHub Study
Research type
Research Study
Full title
An Observational Study to Evaluate BD PureHub™ Disinfecting Cap Use on Needle-Free Connector
IRAS ID
306894
Contact name
Regina B De Jesus
Contact email
Sponsor organisation
Becton, Dickinson and Company
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
Introduction of bacteria into the bloodstream via catheters or other vascular access devices can come from several sources, including contamination of the device prior to the insertion into the skin, contamination of the infusate as well as a contamination via the catheter hub and can result in bloodstream infections. To prevent such an infection, needle-free connectors are used to seal the catheter hub and these connectors can be more easily disinfected. One method to do this is to use alcohol-impregnated disinfectant caps. Theses caps are intended to simplify the cleaning process through passive disinfection, meaning the caps are twisted on the needle-free connectors and the alcohol eliminates bacteria before they can access the catheter hub. Additionally, the disinfecting cap acts as a physical barrier between line accesses of the catheter.
Since 2019. the BD PureHubTM Disinfecting Cap is a marketed medical device in the European Union and the UK and it is compatible with the market-leading needle-free connectors. The BD PureHubTM Disinfecting Cap is comprised of a threaded plastic cap containing a porous pad which has been saturated with Isopropyl Alcohol as disinfectant. The cap is applied to a needle-free connector by pushing and twisting. It will disinfect the connector within one minute and will also act as a physical barrier for up to seven (7) days, if not removed.
The PureHub Study aims to evaluate the safety and performance of the BD PureHubTM Disinfecting Cap when it is used on a day-to-day basis at a hospital as part of the routine care, to reconfirm that the cap is working safely and as intended. There are no additional interventions or procedures planned on behalf of the study, only observational data collection will be performed to obtain data related to the PureHub cap when used in a clinical environment
Adult patients that require vascular access devices that use needle free connectors as part of their standard routine medical care are eligible to be enrolled in the study. Participants are expected to be in the study for a minimum of 7 days and can continue up to 45 days, provided the vascular access device is still in place and the participant is available for regular observations. The collected study data will focus on the attachment and removal success rate of the PureHub cap to/from the needle-free connector, the rate of device/procedure related adverse events and other information i.e. number of caps used per day and per patient, the reason for removing the cap as well as the occurrence of bloodstream infections.
The study data will be used to satisfy regulatory requirements and to demonstrate that the PureHub disinfecting cap continues to comply with these requirements, to finally keep the device on the EU/UK market.REC name
London - Dulwich Research Ethics Committee
REC reference
21/PR/1441
Date of REC Opinion
21 Dec 2021
REC opinion
Further Information Favourable Opinion