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
301396
Contact name
Regina B De Jesus
Contact email
Sponsor organisation
Becton, Dickinson and Company
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
The PureHub Study aims to collect real world data on a CE certified medical device (BD PureHub™ Disinfecting Cap) to provide clinical data required under EU regulation 2017/745, when used as intended. The BD PureHub™ Disinfecting Cap is an alcohol-impregnated cap which is developed to simplify the disinfection process for vascular access devices such as central venous catheters, peripheral intravenous catheters etc. that use needle-free connectors as sealing on the catheter hub. The cap is intended to be used as a disinfecting device for swabbable needle-free luer connectors and to act as a physical barrier to protect the catheter hubs for up to 7 days. The aim is to reduce bacterial contamination of the catheter hub and thereby to reduce the occurrence of catheter related blood stream infections. Any patients that require vascular access devices that use needle free connectors as part of their standard routine medical care are eligible to enroll in the study. The participants will be treated as part of their regular care. Participants will be in the study for up to 45 days and are not required to undergo any additional procedures or visits as part of the study.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
21/PR/1248
Date of REC Opinion
24 Sep 2021
REC opinion
Unfavourable Opinion