Evaluating the BD PosiFlush™ SafeScrub for catheter-related infections
An Investigational Study to Evaluate the Safety and Performance of the BD PosiFlush™ SafeScrub on Needleless Access Devices
This study is testing if the BD PosiFlush™ SafeScrub can help prevent infections in patients with certain types of vascular access devices in a hospital setting.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Becton, Dickinson and Company Industry-sponsored |
| Locations | 1 site (Vienna) |
| Trial ID | NCT06604026 on ClinicalTrials.gov |
What this trial studies
This investigational study aims to assess the safety and performance of the BD PosiFlush™ SafeScrub on needleless access devices in patients with in-situ vascular access devices. Conducted in a high acuity hospital setting, the study will collect clinical data to support regulatory submissions in the EU. Participants will undergo two accesses with the device, with observations made for safety and efficacy. The study includes patients aged 18 and older who have specific types of vascular access devices.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with in-situ vascular access devices in a high acuity medical or surgical unit.
Not a fit: Patients whose medical care would be compromised by observation or who cannot provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and reduced infection rates for patients using vascular access devices.
How similar studies have performed: While this specific approach is investigational, similar studies evaluating safety and performance of vascular access devices have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vienna
- Medical University Vienna — Vienna, Austria (Recruiting)
Study contacts
- Study coordinator: Stephan Hofmann
- Email: Stephan.Hofmann@bd.com
- Phone: 01601053421
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.