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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | use of the BD PosiFlush™ SafeScrub device |
|
| Control Arm | Active Comparator | pre-filled saline syringe (BD PosiFlush™ SP Syringe) and alcohol pad |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BD PosiFlush™ SafeScrub | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Any patient in whom observation might interfere with medical care or create undue hardship as determined by the patients care team.
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| Name | Affiliation | Role |
|---|---|---|
| Christophe Van Laethem | Becton, Dickinson and Company BD Medication Delivery Systems/Catheter Care | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ordensklinikum Linz Elisabethinen | Linz | Upper Austria | 4020 | Austria | ||
| Medical University Vienna |
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At each participating site, one medical or surgical unit will conduct the treatment arm and one unit will conduct the control arm randomizing which unit will perform the treatment or control arm at the study site.
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|
| BD PosiFlush™ | Device | 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. |
|
| 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 |
| Vienna |
| Austria |