Trial Outcomes & Findings for A Post-Market Clinical Follow Up Study to Evaluate BD PureHub™ Disinfecting Cap Use on Needle-Free Connectors (NCT NCT05130762)

Last Updated: 2025-01-27

Results Overview

* 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)

Recruitment status

COMPLETED

Study phase

Target enrollment

157 participants

Primary outcome timeframe

Up to 45 days post-enrollment date

Results posted on

2025-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	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. BD PureHub™ Disinfecting Cap Placements: Attachments/removals: Attachment/Removals of BD PureHub™ Disinfecting Cap
Overall Study STARTED	157
Overall Study COMPLETED	156
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Post-Market Clinical Follow Up Study to Evaluate BD PureHub™ Disinfecting Cap Use on Needle-Free Connectors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	General Cohort n=157 Participants 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. BD PureHub™ Disinfecting Cap Placements: Attachments/removals: Attachment/Removals of BD PureHub™ Disinfecting Cap
Age, Categorical <=18 years	8 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	78 Participants n=5 Participants
Age, Categorical >=65 years	71 Participants n=5 Participants
Age, Continuous	57.5 years STANDARD_DEVIATION 20.74 • n=5 Participants
Sex: Female, Male Female	77 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	154 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Austria	30 participants n=5 Participants
Region of Enrollment Belgium	14 participants n=5 Participants
Region of Enrollment Italy	48 participants n=5 Participants
Region of Enrollment Spain	65 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 45 days post-enrollment date

Population: The primary objective was to assess the rate of select performance measures (attachment success rate \& removal success rate) of the BD PureHub™ Disinfecting Caps on swabbable NFC when used in a clinical environment.

Outcome measures

Outcome measures
Measure	Attachment n=156 Participants 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. BD PureHub™ Disinfecting Cap Placements:Attachment of BD PureHub™ Disinfecting Cap	Removals n=156 Participants 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. BD PureHub™ Disinfecting Cap Placements: Removals of BD PureHub™ Disinfecting Cap
Attachment & Removal Success Rate of the BD PureHub Disinfecting Caps to a Needle-free Connector	99.9 percentage of attachment success rate Interval 99.6 to 100.0	99.7 percentage of attachment success rate Interval 99.2 to 99.9

PRIMARY outcome

Timeframe: Up to 45 days post-enrollment date

Population: AEs in the Enrolled Population

Rate of device-related adverse events

Outcome measures

Outcome measures
Measure	Attachment n=157 Participants 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. BD PureHub™ Disinfecting Cap Placements:Attachment of BD PureHub™ Disinfecting Cap	Removals 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. BD PureHub™ Disinfecting Cap Placements: Removals of BD PureHub™ Disinfecting Cap
Number of Participants With BD PureHub™ Disinfecting Cap Device-related Adverse Events.	0 participants	—

Adverse Events

General Cohort

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	General Cohort n=157 participants at risk 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. BD PureHub™ Disinfecting Cap Placements: Attachments/removals: Attachment/Removals of BD PureHub™ Disinfecting Cap
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.64% 1/157 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory insufficiency	0.64% 1/157 • Number of events 1 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Stephan Hofmann

Becton, Dickinson and Company

Phone: +49 160 105 3421

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place