This study is an investigational study to evaluate the safety and performance of the BD PosiFlush™ SafeScrub on needleless access devices.
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
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
220
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.
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.
Ordensklinikum Linz Elisabethinen
Linz, Upper Austria, Austria
RECRUITINGMedical University Vienna
Vienna, Austria
TERMINATEDDevice related adverse events
To assess the incidence of BD PosiFlush™ SafeScrub device-related adverse events up to 15 min after each access
Time frame: 15 minutes
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
Time frame: 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
Time frame: 15 minutes
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