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

Completed

• Conditions: Catheter Related Complication; Vascular Access Site Management; Disinfecting Cap

• Registration Number: NCT05130762
• Lead Sponsor: Becton, Dickinson and Company

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).

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 Timeline

• Study First Submitted: 2021-10-08
• Study First Submitted QC: 2021-11-11
• Study First Posted: 2021-11-23
• Study Start: 2022-01-31
• Primary Completion: 2023-05-22
• Study Completion: 2023-05-22
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (5)

Medical University Vienna; 🇦🇹 Vienna, Austria

UZA; 🇧🇪 Antwerp, Belgium

Hospital Universitario de A Coruña; 🇪🇸 A Coruña, Spain

Hospital Universitari Arnau de Vilanova; 🇪🇸 Valencia, Spain

Azienda Ospedaliera Universitaria Careggi; 🇮🇹 Florence, Italy