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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights
Study 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 belowSelect...
I need a central venous catheter for my treatment or nutritional support.
Select...
I am between 0 and 10 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
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 moreTrial 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.
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.
Comparative efficacy of 13 antimicrobial dressings and different securement devices in reducing catheter-related bloodstream infections: A Bayesian network meta-analysis.
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Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,193 Previous Clinical Trials
3,161,819 Total Patients Enrolled
Peter Nichol, MD, PhDPrincipal InvestigatorUW School of Medicine and Public Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need a central venous catheter for my treatment or nutritional support.I am between 0 and 10 years old.I am older than 10 years.
Research Study Groups:
This trial has the following groups:- Group 1: Ben-Guard user
- Group 2: Retrospective match control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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