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Device

Wearable Central Line Securement Device (Vest) for Pediatric Disorders

N/A
Waitlist Available
Led By Angelica Mazzarini, MD
Research Sponsored by Ryan St. Pierre-Hetz
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for a maximum of 1 year from enrollment
Awards & highlights

Summary

This trial is testing a new wrap designed to hold central lines in place for children. The goal is to see if this wrap can reduce problems like line breaks, dislodgments, and infections compared to current methods. The study also aims to find out if using the wrap can improve the children's quality of life by allowing them more freedom to move around.

Eligible Conditions
  • Pediatric Disorders
  • Central Line Infection
  • Short Bowel Syndrome
  • Quality of Life
  • Central Line Bloodstream Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for a maximum of 1 year from enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and for a maximum of 1 year from enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
- Line Breaks
- Line Dislodgment
- Line Infections
Secondary outcome measures
Change from baseline in child activity level at 12 months
Change from baseline in child activity level at 3 months
Change from baseline in child activity level at 6 months
+21 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DeviceExperimental Treatment1 Intervention
Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study.
Group II: Traditional Securement DressingActive Control1 Intervention
Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care.

Find a Location

Who is running the clinical trial?

Ryan St. Pierre-HetzLead Sponsor
Angelica Mazzarini, MDPrincipal InvestigatorUPMC Children's Hospital of Pittsburgh
~41 spots leftby Sep 2025
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