An interventional study of BD PureHub™ Disinfecting Cap Placements: Attachments/removals in Catheter Related Complication, Vascular Access Site Management and Disinfecting Cap, sponsored by Becton, Dickinson and Company. Completed at 5 sites in 4 countries. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by Becton, Dickinson and Company · Not applicable, Interventional, and Other
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).
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.
Becton, Dickinson and Company is the lead sponsor of 60 studies on the registry; 5 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Attachment & Removal 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 (successful attachment/total number of attachments) * Removal success rate of the BD PureHub™ Disinfecting Caps to a needle-free connector (successful removal/ total number of intended removals)
Time frame: Up to 45 days post-enrollment date
Number of Participants With BD PureHub™ Disinfecting Cap Device-related Adverse Events.
Rate of device-related adverse events
Time frame: Up to 45 days post-enrollment date
| Milestone | General Cohort |
|---|---|
| Started | 157 |
| Completed | 156 |
| Not completed | 1 |
* Attachment success rate of the BD PureHub™ Disinfecting Caps to a needle-free connector (successful attachment/total number of attachments) * Removal success rate of the BD PureHub™ Disinfecting Caps to a needle-free connector (successful removal/ total number of intended removals)
| percentage of attachment success rate | Attachment | Removals |
|---|---|---|
| Attachment & Removal Success Rate of the BD PureHub Disinfecting Caps to a Needle-free Connector | 99.9 (99.6 to 100) | 99.7 (99.2 to 99.9) |
Rate of device-related adverse events
| participants | General Cohort |
|---|---|
| Number of Participants With BD PureHub™ Disinfecting Cap Device-related Adverse Events. | 0 |
Collected over Participants were followed from the time of enrollment until one week post VAD therapy, department/hospital discharge or 45 days post enrollment date, whichever came first.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| General Cohort | 2/157 (1.3%) | 2/157 (1.3%) | 0/157 (0%) |
| Event | General Cohort |
|---|---|
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/157 |
| Respiratory insufficiencyRespiratory, thoracic and mediastinal disorders | 1/157 |
Enrolled: All participants who signed the ICF Evaluable : All enrolled participants who had at least 1 BD PureHub™ Disinfecting Cap applied.
| Age, Categorical(Participants) | General Cohort |
|---|---|
| <=18 years | 8 |
| Between 18 and 65 years | 78 |
| >=65 years | 71 |
| Age, Continuous(years) | General Cohort |
|---|---|
| Mean | 57.5 ± 20.74 |
| Sex: Female, Male(Participants) | General Cohort |
|---|---|
| Female | 77 |
| Male | 80 |
| Race (NIH/OMB)(Participants) | General Cohort |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 154 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | General Cohort |
|---|---|
| Austria | 30 |
| Belgium | 14 |
| Italy | 48 |
| Spain | 65 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Becton, Dickinson and Company