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OpenTrials
Completed

NCT Number: NCT05109338

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

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.

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Key information

Conditions

Central Venous Catheters

Age range

0 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American Family Children's Hospital

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Mean Number of CVC Fractures

    Time frame: Up to 18 months

    compared to retrospective cohort

Secondary outcomes

  1. Mean Number of CVC Dislodgements

    Time frame: Up to 18 months

    The frequency of CVC dislodgements compared to a matched retrospective cohort.

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

    Time frame: Up to 18 months

    Number of central-line associated blood stream infections compared to a matched retrospective cohort.

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

    Time frame: Up to 18 months

    The number of CVC-related emergency department visits compared to a matched retrospective cohort.

  4. Mean CVC-related Total Healthcare Associated Costs

    Time frame: Up to 18 months

    Mean CVC-related total healthcare-associated costs compared to a matched retrospective cohort.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 5, 2021
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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