An Observational Study to Evaluate BD PureHub™ Disinfecting Cap Use on Needle-Free Connectors

Catheter Related Complication Clinical Trial

Official title:

An Observational Study to Evaluate BD PureHub™ Disinfecting Cap Use on Needle-Free Connectors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05130762
• Other study ID #: MDS-20PUREU001
• Status: Completed
• Start date: January 31, 2022
• Est. completion date: May 22, 2023

Study information

• Verified date: June 2023
• Source: Becton, Dickinson and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: May 22, 2023
• Est. primary completion date: May 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter Related Complication

Intervention

Device:
• BD PureHub™ Disinfecting Cap Placements: Attachments/removals
Attachment/Removals of BD PureHub™ Disinfecting Cap

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna
Belgium	UZA	Antwerp
Italy	Azienda Ospedaliera Universitaria Careggi	Florence
Spain	Hospital Universitario de A Coruña	A Coruña
Spain	Hospital Universitari Arnau de Vilanova	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Becton, Dickinson and Company

Countries where clinical trial is conducted

Austria,  Belgium,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Incidence of BD PureHub™ Disinfecting Cap Device-related Adverse Events.		Up to 45 days post-enrollment date