N/A
Completed N=157
A Post-Market Clinical Follow Up Study to Evaluate BD PureHub™ Disinfecting Cap Use on Needle-Free Connectors
Catheter Related Complication · Vascular Access Site Management · Disinfecting Cap
Source: ClinicalTrials.gov NCT05130762 ↗
Enrolled (actual)
157
Serious AEs
1.3%
Results posted
Jan 2025
Primary outcomePrimary: Attachment & Removal Success Rate of the BD PureHub Disinfecting Caps to a Needle-free Connector — 99.9; 99.7 percentage of attachment success rate
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Attachment & Removal Success Rate of the BD PureHub Disinfecting Caps to a Needle-free Connector |
99.9; 99.7 | — |
| PRIMARY Number of Participants With BD PureHub™ Disinfecting Cap Device-related Adverse Events. |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05130762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.