NCT06604026

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• CRBSI - Catheter Related Bloodstream Infection

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-10-22
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2024-09-19
• Last updated: 2026-02-17

Locations

2 sites across 1 country: Austria