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

NCT05130762 | Completed Results

• 1 other identifier: MDS-20PUREU001
• Study Type: interventional
• Target: 157
• Locations: 4 countries
• Sites: 5

Brief Summary

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).

Conditions

Catheter Related Complication; Vascular Access Site Management; Disinfecting Cap

Outcome Measures

Primary Outcomes (2)

• Attachment & Removal 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 (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)

  Up to 45 days post-enrollment date

• Number of Participants With BD PureHub™ Disinfecting Cap Device-related Adverse Events.

  Rate of device-related adverse events

  Up to 45 days post-enrollment date

Study Arms (1)

General Cohort

OTHER

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

Interventions

BD PureHub™ Disinfecting Cap Placements: Attachments/removals DEVICE

Attachment/Removals of BD PureHub™ Disinfecting Cap

General Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (5)

Medical University Vienna

Vienna, Austria

Location

UZA

Antwerp, Belgium

Location

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Location

Hospital Universitario de A Coruña

A Coruña, Spain

Location

Hospital Universitari Arnau de Vilanova

Valencia, Spain

Location

Results Point of Contact

• Title: Stephan Hofmann
• Organization: Becton, Dickinson and Company

Stephan.Hofmann@bd.com

+49 160 105 3421

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: November 23, 2021
• Study Start: January 31, 2022
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: January 27, 2025
• Results First Posted: January 27, 2025

Record last verified: 2024-03

Locations

AU (1); BE (1); ES (2); IT (1)