An Investigational Study to Evaluate the Safety and Performance of the BD PosiFlush™ SafeScrub on Needleless Access Devices

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is an investigational study to evaluate the safety and performance of the BD PosiFlush™ SafeScrub on needleless access devices.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Austria
Ordensklinikum Linz Elisabethinen
RECRUITING
Linz
Medical University Vienna
RECRUITING
Vienna
Contact Information
Primary
Sabine Riedl
sabine.riedl@bd.com
+491715550267
Backup
Christophe Van Laethem
Christophe.Van.Laethem@bd.com
0477779202
Time Frame
Start Date: 2024-10-22
Estimated Completion Date: 2025-11-28
Participants
Target number of participants: 220
Treatments
Experimental: Treatment arm
use of the BD PosiFlush™ SafeScrub device
Active_comparator: Control Arm
pre-filled saline syringe (BD PosiFlush™ SP Syringe) and alcohol pad
Related Therapeutic Areas
Sponsors
Leads: Becton, Dickinson and Company

This content was sourced from clinicaltrials.gov