Investigational Study With the BD PosiFlush™ SafeScrub on NADs

Not Applicable

Recruiting

• Conditions: CRBSI - Catheter Related Bloodstream Infection
• Interventions: Device: BD PosiFlush™ SafeScrub; Device: BD PosiFlush™

• Registration Number: NCT06604026
• Lead Sponsor: Becton, Dickinson and Company

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.

Study Timeline

• Study First Submitted: 2024-08-21
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-18
• Study First Posted: 2024-09-19
• Study Start: 2024-10-22
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-03-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. 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.
2. Expected to be available until 2 accesses are completed and for any periodic observation upto 15 min after each access.
3. Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant.

Read More

Exclusion Criteria

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
• 0.9% 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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment arm	BD PosiFlush™ SafeScrub	use of the BD PosiFlush™ SafeScrub device
Control Arm	BD PosiFlush™	pre-filled saline syringe (BD PosiFlush™ SP Syringe) and alcohol pad

Primary Outcome Measures

Name	Time	Method
Device related adverse events	15 minutes	To assess the incidence of BD PosiFlush™ SafeScrub device-related adverse events up to 15 min after each access

Secondary Outcome Measures

Name	Time	Method
Compliance rate of device scrubbing	15 minutes	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
Device success rate	15 minutes	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

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria