Investigational Study With the BD PosiFlush™ SafeScrub on NADs

An Investigational Study to Evaluate the Safety and Performance of the BD PosiFlush™ SafeScrub on Needleless Access Devices

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

Study Overview

• Status: Completed
• Conditions: CRBSI - Catheter Related Bloodstream Infection
• Intervention / Treatment: Device: BD PosiFlush™ SafeScrub; Device: BD PosiFlush™

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Medical University Vienna
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Ordensklinikum Linz Elisabethinen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm; use of the BD PosiFlush™ SafeScrub device	Device: BD PosiFlush™ SafeScrub; Clinicians will be advised to use BD PosiFlush™ SafeScrub as per the Instructions for Use for the treatment arm of the study. An independent nurse observer will observe and document any adverse events (e.g. local skin reaction, or irritation, or allergic response, up to and including symptoms of anaphylaxis), compliance with needleless access device scrubbing before flushing, device success rate (encapsulation and removal) as well as the time requirements and number of steps for needleless access device scrubbing prior to catheter flushes during medication administration process.
Active Comparator: Control Arm; pre-filled saline syringe (BD PosiFlush™ SP Syringe) and alcohol pad	Device: BD PosiFlush™; Clinicians will be advised to follow and document the respective unit protocol, while using the standard pre-filled syringe (BD PosiFlush™ SP Syringe) and alcohol pad for scrubbing and flushing of NADs in the control arm of the study as the routine practice. An independent nurse observer will observe and document any adverse events (e.g. local skin reaction, or irritation, or allergic response, up to and including symptoms of anaphylaxis), compliance with needleless access device scrubbing before flushing, device success rate (encapsulation and removal) as well as the time requirements and number of steps for needleless access device scrubbing prior to catheter flushes during medication administration process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device related adverse events	To assess the incidence of BD PosiFlush™ SafeScrub device-related adverse events up to 15 min after each access	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance rate of device scrubbing	To assess if the compliance rate of needleless access device scrubbing before flushing with use of BD PosiFlush™ SafeScrub is higher compared to standard practice (i.e., use of pre-filled syringe (BD PosiFlush™ SP Syringe) and an alcohol pad) up to 15 min after each access	15 minutes
Device success rate	To assess the performance of the BD PosiFlush™ SafeScrub. Percent success rate (≥85%) for BD PosiFlush™ SafeScrub to encapsulate the needleless access device, and to be removed from the needleless access device up to 15 min after each access	15 minutes

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company
• Investigators: Study Chair: Christophe Van Laethem, Becton, Dickinson and Company BD Medication Delivery Systems/Catheter Care

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Actual): April 30, 2026
• Study Completion (Actual): April 30, 2026

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Fibrinolytic Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: MDS-23PFINTEU001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No