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Device
Innovative Central Line Securement Device in the Pediatric Population
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
No Placebo-Only Group
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
- Short Bowel Syndrome
- Quality of Life
- Central Line Infection
- Central Line Bloodstream Infection
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for a maximum of 1 year from enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for a maximum of 1 year from enrollment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
- Line Breaks
- Line Infections
- Line Replacement
Secondary study objectives
Are You Worried About Your Child's Current Health?
Does Having a Central Line Affect His or Her Learning at School?
Does Having a Central Line Affect His/Her Participation in School?
+24 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DeviceExperimental Treatment2 Interventions
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.
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Who is running the clinical trial?
Ryan St. Pierre-HetzLead Sponsor
Angelica Mazzarini, MDPrincipal InvestigatorUPMC Children's Hospital of Pittsburgh