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

Central Venous Catheters Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05109338
• Other study ID #: 2021-0781
• Secondary ID: Protocol Version
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: April 5, 2024

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 5, 2024
• Est. primary completion date: April 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Venous Catheters

Intervention

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.

Locations

Country	Name	City	State
United States	American Family Children's Hospital	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Number of CVC Fractures	compared to retrospective cohort	Up to 18 months
Secondary	Mean Number of CVC Dislodgements	The frequency of CVC dislodgements compared to a matched retrospective cohort.	Up to 18 months
Secondary	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
Secondary	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
Secondary	Mean CVC-related Total Healthcare Associated Costs	Mean CVC-related total healthcare-associated costs compared to a matched retrospective cohort.	Up to 18 months