What is the mechanism of action of this treatment?

The most common treatments for Central Line Insertion focus on stabilizing the catheter and preventing infections. Securement devices, like sutureless devices, stabilize the catheter to prevent movement, fractures, and dislodgements, which are common complications that increase infection risk. Antimicrobial dressings create a barrier against pathogens, reducing the likelihood of catheter-related bloodstream infections (CRBSIs). These treatments are essential for maintaining catheter integrity and minimizing infection risks, thereby improving patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for central line insertion include the use of antimicrobial lock solutions and devices like the Ben-Guard garment to stabilize tubing. Antimicrobial lock solutions can reduce catheter-related infections (CRI) but may have uncertain effects on thrombosis incidence. The Ben-Guard device aims to prevent tubing fractures and dislodgements, thereby reducing infection risk. Known side effects of central line insertion treatments include infection, thrombosis, and mechanical complications such as catheter dislodgement or fracture.

What prior FDA approvals exist?

There is limited specific information on prior FDA approvals for devices similar to the Ben-Guard, which stabilizes tubing to prevent fractures and dislodgements in central line insertions. Generally, FDA-approved treatments for central line-associated bloodstream infections (CLABSIs) focus on antimicrobial catheters, antiseptic dressings, and securement devices. These interventions aim to reduce infection risk by maintaining catheter stability and ensuring hygienic conditions.

What other types of research exist?

Promising alternatives to Ben-Guard for central line insertion patients include sutureless securement devices and transparent dressings. Sutureless securement devices have been shown to significantly reduce catheter-associated complications by improving securement and reducing catheter motion. Transparent dressings are also recommended for their potential to lower the incidence of catheter-related bloodstream infections.

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Ben-Guard Garment for Pediatric Central Line Complications

N/A

Waitlist Available

Led By Peter Nichol, MD, PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Medical disease or condition that requires a CVC for treatment, supportive care, or nutritional support

Participants age 0-10

Must not have

Age > 10

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if the Ben-Guard, a wearable garment that keeps CVC tubing stable, reduces complications in 40 children over a period of time. The device aims to prevent tubing from breaking or moving, thereby lowering infection risks.

Who is the study for?

This trial is for children aged 0-10 who need a central venous catheter (CVC) for treatment, care, or nutrition and can communicate in English. It's not for those who had a tunneled CVC placed elsewhere or are older than 10.

What is being tested?

The study tests the Ben-Guard Garment to see if it reduces complications like infections by keeping CVC tubing stable in pediatric patients. This pilot study will assess the effectiveness of this wearable device.

What are the potential side effects?

Since the Ben-Guard is a non-invasive garment designed to stabilize CVCs, side effects may be minimal but could include skin irritation or discomfort where the garment touches the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need a central venous catheter for my treatment or nutritional support.

Select...

I am between 0 and 10 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am older than 10 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Number of CVC Fractures

Secondary study objectives

Mean CVC-related Total Healthcare Associated Costs

Mean Number of CVC Dislodgements

Total Number of CVC-related Emergency Department or Urgent Care Visits

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ben-Guard userExperimental Treatment1 Intervention

Participants will wear the garment for up to 18 months while needing a central line catheter.

Group II: Retrospective match controlActive Control1 Intervention

Matched historical control for intervention group based on age, gender and duration of use of a central venous catheter.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ben-Guard Garment

2021

N/A

~20

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Central Line Insertion focus on stabilizing the catheter and preventing infections. Securement devices, like sutureless devices, stabilize the catheter to prevent movement, fractures, and dislodgements, which are common complications that increase infection risk. Antimicrobial dressings create a barrier against pathogens, reducing the likelihood of catheter-related bloodstream infections (CRBSIs). These treatments are essential for maintaining catheter integrity and minimizing infection risks, thereby improving patient outcomes.

Comparative efficacy of 13 antimicrobial dressings and different securement devices in reducing catheter-related bloodstream infections: A Bayesian network meta-analysis.