MedTrace Logo

Innovative Central Line Securement Device in the Pediatric Population

NCT04522778 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-07-05

Study results available
· View outcomes & findings →

Summary

This study involves evaluating pediatric patients with central lines to determine differences in line complications and quality of life in those with a novel central line securement device (wrap) as compared to those who use a traditional securement device (dressing).

Conditions

  • Central Line Complication
  • Central Line Infection
  • Central Line-Associated Infection
  • Central Line Sepsis
  • Short Gut Syndrome
  • Quality of Life
  • Pediatric Disorder

Interventions

DEVICE

Wearable Central Line Securement Device (Vest)

The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.

OTHER

Traditional Securement Dressing

All subjects will use sterile dressings throughout the trial as this is the standard of care for central line securement. Subjects randomized to the dressing arm will continue to use standard of care sterile dressing as the only form of central line securement.

Sponsors & Collaborators

  • Ryan St. Pierre-Hetz

    lead OTHER

Principal Investigators

  • Angelica Mazzarini, MD · UPMC Children's Hospital of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-05
Primary Completion
2022-09-15
Completion
2023-05-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04522778 on ClinicalTrials.gov