Investigational Study With the BD PosiFlush™ SafeScrub on NADs

NCT06604026 | Completed

• 1 other identifier: MDS-23PFINTEU001
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

CRBSI - Catheter Related Bloodstream Infection

Outcome Measures

Primary Outcomes (1)

• Device related adverse events

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

  15 minutes

Secondary Outcomes (2)

• Compliance rate of device scrubbing

  15 minutes

• Device success rate

  15 minutes

Study Arms (2)

Treatment arm

EXPERIMENTAL

use of the BD PosiFlush™ SafeScrub device

Device: BD PosiFlush™ SafeScrub

Control Arm

ACTIVE COMPARATOR

pre-filled saline syringe (BD PosiFlush™ SP Syringe) and alcohol pad

Device: BD PosiFlush™

Interventions

BD PosiFlush™ SafeScrub DEVICE

Clinicians will be advised to use BD PosiFlush™ SafeScrub as per the Instructions for Use for the treatment arm of the study. An independent nurse observer will observe and document any adverse events (e.g. local skin reaction, or irritation, or allergic response, up to and including symptoms of anaphylaxis), compliance with needleless access device scrubbing before flushing, device success rate (encapsulation and removal) as well as the time requirements and number of steps for needleless access device scrubbing prior to catheter flushes during medication administration process.

Treatment arm

BD PosiFlush™ DEVICE

Clinicians will be advised to follow and document the respective unit protocol, while using the standard pre-filled syringe (BD PosiFlush™ SP Syringe) and alcohol pad for scrubbing and flushing of NADs in the control arm of the study as the routine practice. An independent nurse observer will observe and document any adverse events (e.g. local skin reaction, or irritation, or allergic response, up to and including symptoms of anaphylaxis), compliance with needleless access device scrubbing before flushing, device success rate (encapsulation and removal) as well as the time requirements and number of steps for needleless access device scrubbing prior to catheter flushes during medication administration process.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• % 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

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (2)

Ordensklinikum Linz Elisabethinen

Linz, Upper Austria, 4020, Austria

Location

Medical University Vienna

Vienna, Austria

Location

Study Officials

• Christophe Van Laethem

  Becton, Dickinson and Company BD Medication Delivery Systems/Catheter Care

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: September 19, 2024
• Study Start: October 22, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)