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

Not Applicable

Completed

• Conditions: Central Venous Catheters
• Interventions: Device: Ben-Guard Garment

• Registration Number: NCT05109338
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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.

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 Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-11-05
• Primary Completion: 2024-04-05
• Study Completion: 2024-04-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ben-Guard user	Ben-Guard Garment	Participants will wear the garment for up to 18 months while needing a central line catheter.

Primary Outcome Measures

Name	Time	Method
Mean Number of CVC Fractures	Up to 18 months	compared to retrospective cohort

Secondary Outcome Measures

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

Trial Locations

Locations (1)

American Family Children's Hospital; 🇺🇸 Madison, Wisconsin, United States