Skip to main content
OpenTrials
Completed

NCT Number: NCT05130762

A Post-Market Clinical Follow Up Study to Evaluate BD PureHub™ Disinfecting Cap Use on Needle-Free Connectors

The study will collect use data of the Becton Dickinson (BD) PureHub™ Disinfecting Cap in combination with needle-free connectors, which are attached to vascular access devices (VAD).

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Vienna, Vienna, Austria

Loading trial locations.

About this study

This is a multi-center, prospective observational study of a minimum of 150 study participants who have vascular access devices (VADs) with needle-free connectors as part of their routine medical care.

Patients will be followed from the time of enrollment through the duration of VAD therapy or 45 days post enrollment date, whichever comes first.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has an eligible vascular access device with needle-free connectors in situ or will have one placed Note: This covers all needle-free devices, including central venous catheters, peripheral IV catheters and arterial VADs
  • Is expected to receive VAD therapy for a minimum of 3 days
  • Is expected to be available for regular observation from consent until end of study
  • Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant

Exclusion criteria

  • BD PureHub™ Disinfecting Cap or any other disinfecting cap in place for more than twelve (12) hours (>12 hours) prior to study participation
  • Presence of any infection, bacteremia, or septicemia is known or suspected
  • Any condition which, in the opinion of the Investigator, precludes the participant from participation in this study

Treatment and study plan

BD PureHub™ Disinfecting Cap Placements: Attachments/removals

Device

Attachment/Removals of BD PureHub™ Disinfecting Cap

Primary outcomes

  1. Attachment & Removal Success Rate of the BD PureHub Disinfecting Caps to a Needle-free Connector

    Time frame: Up to 45 days post-enrollment date

    • Attachment success rate of the BD PureHub™ Disinfecting Caps to a needle-free connector (successful attachment/total number of attachments)
    • Removal success rate of the BD PureHub™ Disinfecting Caps to a needle-free connector (successful removal/ total number of intended removals)
  2. Number of Participants With BD PureHub™ Disinfecting Cap Device-related Adverse Events.

    Time frame: Up to 45 days post-enrollment date

    Rate of device-related adverse events

Sponsors and collaborators

Lead sponsor

Becton, Dickinson and Company

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 23, 2021
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.