NCT05109338

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 0 Years – 10 Years
• Healthy volunteers: Accepted

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.

Conditions

• Central Venous Catheters

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-04-05
• Completion: 2024-04-05
• First posted: 2021-11-05
• Last updated: 2024-05-31

Locations

1 site across 1 country: United States