Catheter Related Complication, Disinfecting Cap, Vascular Access Site Management
Conditions
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).
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.
Interventions
DEVICEBD PureHub™ Disinfecting Cap Placements: Attachments/removals
Attachment/Removals of BD PureHub™ Disinfecting Cap
Sponsors
Becton, Dickinson and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. 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 2. Is expected to receive VAD therapy for a minimum of 3 days 3. Is expected to be available for regular observation from consent until end of study 4. Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant
Exclusion criteria
1. BD PureHub™ Disinfecting Cap or any other disinfecting cap in place for more than twelve (12) hours (\>12 hours) prior to study participation 2. Presence of any infection, bacteremia, or septicemia is known or suspected 3. Any condition which, in the opinion of the Investigator, precludes the participant from participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attachment & Removal 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 (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. | Up to 45 days post-enrollment date | Rate of device-related adverse events |
Countries
Austria, Belgium, Italy, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 157 |
| Total | 157 |
Baseline characteristics
| Characteristic | General Cohort |
|---|---|
| Age, Categorical <=18 years | 8 Participants |
| Age, Categorical >=65 years | 71 Participants |
| Age, Categorical Between 18 and 65 years | 78 Participants |
| Age, Continuous | 57.5 years STANDARD_DEVIATION 20.74 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 154 Participants |
| Region of Enrollment Austria | 30 participants |
| Region of Enrollment Belgium | 14 participants |
| Region of Enrollment Italy | 48 participants |
| Region of Enrollment Spain | 65 participants |
| Sex: Female, Male Female | 77 Participants |
| Sex: Female, Male Male | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 157 |
| other Total, other adverse events | 0 / 157 |
| serious Total, serious adverse events | 2 / 157 |
Outcome results
Primary
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Attachment | Attachment & Removal Success Rate of the BD PureHub Disinfecting Caps to a Needle-free Connector | 99.9 percentage of attachment success rate |
| Removals | Attachment & Removal Success Rate of the BD PureHub Disinfecting Caps to a Needle-free Connector | 99.7 percentage of attachment success rate |
Primary
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
Population: AEs in the Enrolled Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Attachment | Number of Participants With BD PureHub™ Disinfecting Cap Device-related Adverse Events. | 0 participants |