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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2024-04-05

Brief Summary

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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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Detailed Description

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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

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Central Venous Catheters

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Ben-Guard user

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

Group Type EXPERIMENTAL

Ben-Guard Garment

Intervention Type 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.

Retrospective match control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

0 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes