Investigational Study With the BD PosiFlush™ SafeScrub on NADs

Last updated: December 13, 2024
Sponsor: Becton, Dickinson and Company
Overall Status: Active - Recruiting

Phase

N/A

Condition

Soft Tissue Infections

Treatment

BD PosiFlush™ SafeScrub

BD PosiFlush™

Clinical Study ID

NCT06604026
MDS-23PFINTEU001
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Any patient (≥18 years of age) in a high acuity hospital medical or surgical unitregardless of gender, with an eligible in-situ vascular access device and with aneedleless 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 medicalcare. 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, andneedle-free connectors.

  2. Expected to be available until 2 accesses are completed and for any periodicobservation 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

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 ofsodium or chloride could be clinically detrimental as determined by the studyinvestigator.

  • Patients with a known allergy to any of the followings as determined by the studyinvestigator:

  • Any of the components or materials of BD PosiFlush™ SafeScrub device or BDPosiFlush™ 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 toparticipate in the study

Study Design

Total Participants: 220
Treatment Group(s): 2
Primary Treatment: BD PosiFlush™ SafeScrub
Phase:
Study Start date:
October 22, 2024
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Medical University Vienna

    Vienna,
    Austria

    Active - Recruiting

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