Investigational Study With the BD PosiFlush™ SafeScrub on NADs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-22

Study Completion Date

2025-11-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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CRBSI - Catheter Related Bloodstream Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment arm

use of the BD PosiFlush™ SafeScrub device

Group Type EXPERIMENTAL

BD PosiFlush™ SafeScrub

Intervention Type 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.

Control Arm

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

Group Type ACTIVE_COMPARATOR

BD PosiFlush™

Intervention Type 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.

Interventions

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BD PosiFlush™ SafeScrub

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.

Intervention Type DEVICE

BD PosiFlush™

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No