Efficacy of Ben-Guard Garment in Reducing Pediatric Central Line Complications

Efficacy of Ben-Guard Garment in Reducing the Frequency of Pediatric Central Line Complications: A Pilot Study

Central venous catheter (CVC) insertion is a common surgical procedure performed in children for the delivery of nutritional support, medications, frequent blood draws or transfusions. Maintaining hygienic conditions is absolutely necessary in order to avoid contamination of the catheter and tubing to avoid bloodstream infections. Fractures in the tubing is a common complication that places children at increased risk for infections. In order to help keep the tubing stable to avoid fractures and dislodgements, a wearable device was created called Ben-Guard. This pilot study is being undertaken to determine if the Ben-Guard device will reduce the incidence and severity of adverse events in children requiring CVCs.

Study Overview

• Status: Active, not recruiting
• Conditions: Central Venous Catheters
• Intervention / Treatment: Device: Ben-Guard Garment

Detailed Description

Conduct a pragmatic pilot study of the Ben-Guard Catheter Safety Device in 40 pediatric patients with central venous catheters (CVC). Participants will be issued 3-5 garments, which are expected to be worn at all times. This study will be conducted over an 18 month period. Participants are expected to wear the garment daily for the duration of the study (or duration of their treatment if <18 months). Data will be reviewed every 3 months to measure the garment's acceptability and effect on the frequency of central line-associated complications. Outcomes will be compared to a matched retrospective cohort. This study will use the device consistent with the description as a registered FDA Class 1 device. The investigators are conducting this study to clinically and scientifically evaluate the device's ability to change the frequency of CVC fractures and CVC complications in children.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • American Family Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 10 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants age 0-10
• medical disease or condition that requires a CVC for treatment, supportive care or nutritional support
• English Speaking

Exclusion Criteria:

• Any patient who received a non-tunneled CVC
• Any patient who had a tunneled CVC placed from an outside institution
• Age > 10
• Patients that cannot communicate or read English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ben-Guard user; Participants will wear the garment for up to 18 months while needing a central line catheter.	Device: Ben-Guard Garment; Wearable device designed to secure CVCs and gastrointestinal feeding tubes. The Ben-Guard Catheter Securement Device was designed specifically to better secure and conceal CVC tubing, protecting the patient by keeping tubing closer to the body.
No Intervention: Retrospective match control; Matched historical control for intervention group based on age, gender and duration of use of a central venous catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Number of CVC Fractures	compared to retrospective cohort	Up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Number of CVC Dislodgements	The frequency of CVC dislodgements compared to a matched retrospective cohort.	Up to 18 months
Total Number of Central-Line Associated Blood Stream Infections (CLABSIs)	Number of central-line associated blood stream infections compared to a matched retrospective cohort.	Up to 18 months
Total Number of CVC-related Emergency Department or Urgent Care Visits	The number of CVC-related emergency department visits compared to a matched retrospective cohort.	Up to 18 months
Mean CVC-related Total Healthcare Associated Costs	Mean CVC-related total healthcare-associated costs compared to a matched retrospective cohort.	Up to 18 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Peter Nichol, MD, PhD, UW School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Central venous catheter; complication
• Other Study ID Numbers: 2021-0781; A539790 (Other Identifier: UW Madison); Protocol Version 4/16/2021 (Other Identifier: UW Madison); fund for garments (Other Grant/Funding Number: Cars Curing Kids)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No