Catheter Related ComplicationNCT05130762
A Post-Market Clinical Follow Up Study to Evaluate BD PureHub™ Disinfecting Cap Use on Needle-Free Connectors
A study testing BD PureHub™ Disinfecting Cap Placements: Attachments/removals in people with Catheter Related Complication and Vascular Access Site Management, run by Becton, Dickinson and Company at 5 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Catheter Related Complication, Vascular Access Site Management, Disinfecting Cap
- What is being tested?
- BD PureHub™ Disinfecting Cap Placements: Attachments/removals
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 31 Jan 2022to 22 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Spain2 sites
Hospital Universitario de A Coruña
A Coruña
Hospital Universitari Arnau de Vilanova
Valencia
About this study
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).
Read the 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.
- Being tested
- BD PureHub™ Disinfecting Cap Placements: Attachments/removals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD PureHub™ Disinfecting Cap Placements: Attachments/removalsDevice
Attachment/Removals of BD PureHub™ Disinfecting Cap
| Study group | Role | What they receive |
|---|---|---|
| General Cohort | Other | 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. Receives: Device: BD PureHub™ Disinfecting Cap Placements: Attachments/removals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Up to 45 days post-enrollment date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start31 Jan 2022
- Primary completion22 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Catheter Related ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130762
- Sponsor's protocol ID
- MDS-20PUREU001
- Status last verified
- Mar 2024
- First submitted
- 8 Oct 2021
- Last updated
- 27 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Clinical Follow Up Study to Evaluate BD PureHub™ Disinfecting Cap Use on Needle-Free Connectors
- ClinicalTrials.gov ID
- NCT05130762
- Acronym / sponsor ID
- MDS-20PUREU001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Posted 27 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General Cohort | Other | Device: BD PureHub™ Disinfecting Cap Placements: Attachments/removalsAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BD PureHub™ Disinfecting Cap Placements: Attachments/removalsAttachment/Removals of BD PureHub™ Disinfecting Cap | Device | General Cohort |
Primary outcome
Attachment & Removal Success Rate of the BD PureHub Disinfecting Caps to a Needle-free Connector
Time frame: Up to 45 days post-enrollment date
* 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)
Number of Participants With BD PureHub™ Disinfecting Cap Device-related Adverse Events.
Time frame: Up to 45 days post-enrollment date
Rate of device-related adverse events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BD PureHub™ Disinfecting Cap Placements: Attachments/removals in people with Catheter Related Complication and Vascular Access Site Management, run by Becton, Dickinson and Company at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, Austria, Belgium, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attachment & Removal Success Rate of the BD PureHub Disinfecting Caps to a Needle-free Connector (time frame: Up to 45 days post-enrollment date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.