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Investigational Study With the BD PosiFlush™ SafeScrub on NADs
Sponsor: Becton, Dickinson and Company
Summary
This study is an investigational study to evaluate the safety and performance of the BD PosiFlush™ SafeScrub on needleless access devices.
Official title: An Investigational Study to Evaluate the Safety and Performance of the BD PosiFlush™ SafeScrub on Needleless Access Devices
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2024-10-22
Completion Date
2026-02-28
Last Updated
2026-02-17
Healthy Volunteers
No
Interventions
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.
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.
Locations (2)
Ordensklinikum Linz Elisabethinen
Linz, Upper Austria, Austria
Medical University Vienna
Vienna, Austria