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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

Summary

This trial is testing a device to see if it helps reduce complications in children with central venous catheters.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Number of CVC Fractures
Secondary outcome measures
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

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

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.

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,198 Previous Clinical Trials
3,162,252 Total Patients Enrolled
Peter Nichol, MD, PhDPrincipal InvestigatorUW School of Medicine and Public Health

Media Library

Ben-Guard Garment Clinical Trial Eligibility Overview. Trial Name: NCT05109338 — N/A
Central Line Insertion Research Study Groups: Ben-Guard user, Retrospective match control
Central Line Insertion Clinical Trial 2023: Ben-Guard Garment Highlights & Side Effects. Trial Name: NCT05109338 — N/A
Ben-Guard Garment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05109338 — N/A
~3 spots leftby Jul 2025