Clinical trial NCT06604026: Investigational Study With the BD PosiFlush™ SafeScrub on NADs
Official title: An Investigational Study to Evaluate the Safety and Performance of the BD PosiFlush™ SafeScrub on Needleless Access Devices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CRBSI - Catheter Related Bloodstream Infection
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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 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.

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

Primary outcomes:
measure: Device related adverse events
timeFrame: 15 minutes
Secondary outcomes:
measure: Compliance rate of device scrubbing
timeFrame: 15 minutes
measure: Device success rate
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
affiliation: Becton, Dickinson and Company BD Medication Delivery Systems/Catheter Care
name: Christophe Van Laethem
role: STUDY_CHAIR
References: