Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05109338 |
Other study ID # |
2021-0781 |
Secondary ID |
Protocol Version |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.