An Observational 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).

Study Overview

• Status: Completed
• Conditions: Catheter Related Complication; Vascular Access Site Management; Disinfecting Cap
• Intervention / Treatment: Device: BD PureHub™ Disinfecting Cap Placements: Attachments/removals

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 157

Contacts and Locations

• Study Contact: Name: Stephan Hofmann, Dr.; Email: Stephan.Hofmann@bd.com

Study Locations

• Austria
  • Vienna, Austria
    • Medical University Vienna
• Belgium
  • Antwerp, Belgium
    • UZA
• Italy
  • Florence, Italy
    • Azienda Ospedaliera Universitaria Careggi
• Spain
  • A Coruña, Spain
    • Hospital Universitario de A Coruna
  • Valencia, Spain
    • Hospital Universitari Arnau de Vilanova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have vascular access devices (VADs) with needle-free connectors as part of their routine medical care.

Description

Inclusion Criteria:

1. 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
2. Is expected to receive VAD therapy for a minimum of 3 days
3. Is expected to be available for regular observation from consent until end of study
4. Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
General Cohort; All patients who receive a VAD as standard of care in combination with needle-free connectors. A BD PureHub™ Disinfecting Cap will be placed on each eligible needle-free connector and all attachments/removals incl. reason for change will be documented up to 45 days post-enrollment date.	Device: BD PureHub™ Disinfecting Cap Placements: Attachments/removals; Attachment/Removals of BD PureHub™ Disinfecting Cap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attachment Success Rate of the BD PureHub Disinfecting Caps to a Needle-free Connector	Attachment success rate of the BD PureHub™ Disinfecting Caps to a needle-free connector defined as successful attachment/total number of attachments.	Up to 45 days post-enrollment date
Removal Success Rate of the BD PureHub™ Disinfecting Caps to a Needle-free Connector	Removal success rate defined as number of successful removal/ total number of intended removals.	Up to 45 days post-enrollment date
Incidence of BD PureHub™ Disinfecting Cap Device-related Adverse Events.		Up to 45 days post-enrollment date

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): May 22, 2023
• Study Completion (Actual): May 22, 2023

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MDS-20PUREU001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No