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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Catheter Related Complication, Vascular Access Site Management, Disinfecting Cap

Intervention / Treatment
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* Device: BD PureHub™ Disinfecting Cap Placements: Attachments/removals


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| General Cohort<br>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<br>* Attachment/Removals of BD PureHub™ Disinfecting Cap<br>|

What is the study measuring?
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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 |