Status:
RECRUITING
Investigational Study With the BD PosiFlush™ SafeScrub on NADs
Lead Sponsor:
Becton, Dickinson and Company
Conditions:
CRBSI - Catheter Related Bloodstream Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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.
- Expected to be available until 2 accesses are completed and for any periodic observation upto 15 min after each access.
- Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
October 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 28 2025
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06604026
Start Date
October 22 2024
End Date
November 28 2025
Last Update
August 19 2025
Active Locations (2)
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1
Ordensklinikum Linz Elisabethinen
Linz, Upper Austria, Austria, 4020
2
Medical University Vienna
Vienna, Austria