An Observational Study to Evaluate BD PureHub™ Disinfecting Cap Use on Needle-Free Connectors
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Is expected to receive VAD therapy for a minimum of 7 days
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Is expected to be available for regular observation from consent until end of study
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Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant
Exclusion Criteria:
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BD PureHub™ Disinfecting Cap or any other disinfecting cap placed prior to study participation
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Presence of any infection, bacteremia, or septicemia is known or suspected
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Any condition which, in the opinion of the Investigator, precludes the participant from participation in this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZA | Antwerp | Belgium |
Sponsors and Collaborators
- Becton, Dickinson and Company
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MDS-20PUREU001