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

NCT05109338 | Completed

• 4 other identifiers: 2021-0781Protocol Version 8/3/2021A539790fund for garments
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Venous Catheters

Keywords

Central venous catheter; complication

Outcome Measures

Primary Outcomes (1)

• Mean Number of CVC Fractures

  compared to retrospective cohort

  Up to 18 months

Secondary Outcomes (4)

• Mean Number of CVC Dislodgements

  Up to 18 months

• Total Number of Central-Line Associated Blood Stream Infections (CLABSIs)

  Up to 18 months

• Total Number of CVC-related Emergency Department or Urgent Care Visits

  Up to 18 months

• Mean CVC-related Total Healthcare Associated Costs

  Up to 18 months

Study Arms (2)

Ben-Guard user

EXPERIMENTAL

Participants will wear the garment for up to 18 months while needing a central line catheter.

Device: Ben-Guard Garment

Retrospective match control

NO INTERVENTION

Matched historical control for intervention group based on age, gender and duration of use of a central venous catheter.

Interventions

Ben-Guard Garment DEVICE

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.

Ben-Guard user

Eligibility Criteria

• Age: 0 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

American Family Children's Hospital

Madison, Wisconsin, 53792, United States

Location

Study Officials

• Peter Nichol, MD, PhD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 5, 2021
• Study Start: October 1, 2021
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)