Clinical trial NCT05109338: Efficacy of Ben-Guard Garment in Reducing Pediatric Central Line Complications
Official title: Efficacy of Ben-Guard Garment in Reducing the Frequency of Pediatric Central Line Complications: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Venous Catheters
Keywords: Central venous catheter
complication
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 12
Sex: ALL
Minimum age (years): 0
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Number of CVC Fractures
timeFrame: Up to 18 months
Secondary outcomes:
measure: Mean Number of CVC Dislodgements
timeFrame: Up to 18 months
measure: Total Number of Central-Line Associated Blood Stream Infections (CLABSIs)
timeFrame: Up to 18 months
measure: Total Number of CVC-related Emergency Department or Urgent Care Visits
timeFrame: Up to 18 months
measure: Mean CVC-related Total Healthcare Associated Costs
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: American Family Children's Hospital
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Peter Nichol, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: