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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2023-05-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluating Central Line Hub Contamination Using a Novel Capping Device

NCT01301300

UNKNOWN PHASE1/PHASE2

The AbsorbaSeal Vascular Closure Device Trial

NCT03730571

Peripheral Arterial Disease

TERMINATED NA

Investigational Study With the BD PosiFlush™ SafeScrub on NADs

NCT06604026

CRBSI - Catheter Related Bloodstream Infection

RECRUITING NA

Study on the Reduction of Catheter-related Infections by Use of Self-disinfecting Venous and Arterial Access Caps

NCT04534348

CLABSI - Central Line Associated Bloodstream Infection Catheter-Related Blood Stream Infection

COMPLETED

Influence of Bionecteurs on Catheter-associated Infection

NCT02134769

Infection

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Catheter Related Complication Vascular Access Site Management Disinfecting Cap

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

BD PureHub™ Disinfecting Cap Placements: Attachments/removals

Intervention Type DEVICE

Attachment/Removals of BD PureHub™ Disinfecting Cap

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BD PureHub™ Disinfecting Cap Placements: Attachments/removals

Attachment/Removals of BD PureHub™ Disinfecting Cap

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No