Investigational Study With the BD PosiFlush™ SafeScrub on NADs

Becton, Dickinson and Company (BD)

Status: Enrolling

Conditions: CRBSI - Catheter Related Bloodstream Infection

Treatments: Device: BD PosiFlush™ SafeScrub; Device: BD PosiFlush™

Study type: Interventional

Funder types: Industry

Identifiers

NCT06604026

MDS-23PFINTEU001

Details and patient eligibility

About

This study is an investigational study to evaluate the safety and performance of the BD PosiFlush™ SafeScrub on needleless access devices.

Full description

This study is being conducted to generate clinical data to support the performance and safety of BD PosiFlush™ SafeScrub. The study data will be used for regulatory submission in EU.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Any patient (≥18 years of age) in a high acuity hospital medical or surgical unit regardless of gender, with an eligible in-situ vascular access device and with a needleless access device (NAD). This includes patients who have a current VAD, whether it is newly placed or long-term access as part of their routine medical care. Eligible in-situ vascular access devices are peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs) and implanted venous access ports. Eligible NADs are stopcocks, Y-sites, and needle-free connectors.
2. Expected to be available until 2 accesses are completed and for any periodic observation upto 15 min after each access.
3. Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant.

Exclusion criteria

Any patient in whom observation might interfere with medical care or create undue hardship as determined by the patients care team.

• Patients under the age of 18.
• Patients suffering hypernatremia and fluid retention, when the administration of sodium or chloride could be clinically detrimental as determined by the study investigator.
• Patients with a known allergy to any of the followings as determined by the study investigator:
• Any of the components or materials of BD PosiFlush™ SafeScrub device or BD PosiFlush™ SP Syringe, or
• 0.9% sodium chloride solution
• Pregnant or breastfeeding women
• Urine pregnancy test will be required for all women of childbearing age who want to participate in the study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Treatment arm

Experimental group

Description:

use of the BD PosiFlush™ SafeScrub device

Treatment:

Device: BD PosiFlush™ SafeScrub

Control Arm

Active Comparator group

Description:

pre-filled saline syringe (BD PosiFlush™ SP Syringe) and alcohol pad

Treatment:

Device: BD PosiFlush™