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

University of Wisconsin (UW)

Status: Completed

Conditions: Central Venous Catheters

Treatments: Device: Ben-Guard Garment

Study type: Interventional

Funder types: Other

Identifiers

NCT05109338

fund for garments (Other Grant/Funding Number)

A539790 (Other Identifier)

2021-0781

Protocol Version 8/3/2021 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: Under 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Ben-Guard user

Experimental group

Description:

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

Treatment:

Device: Ben-Guard Garment

Retrospective match control

No Intervention group

Description:

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