NCT04522778

Innovative Central Line Securement Device in the Pediatric Population

Innovative Central Line Securement Device: Line Complications and Quality of Life in the Pediatric Population as Compared to Traditional Securement Device

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Ryan St. Pierre-Hetz · Academic / Other
• Sex: All
• Age: 0 Years – 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Children with central lines experience line breaks, line dislodgment's and line infections as a result of traditional securement techniques (dressings). These issues lead to the patients' increased health care utilization and possibly to restriction of movement and delayed development as the children are restricted in their home environment. The purpose of this study is to determine if a wearable central line securement device, can decrease the number of line breaks, line dislodgment and line infections as compared to traditional securement techniques. Events per month would be calculated for each arm before and after intervention and analyzed for treatment effect. The hypothesis is that the use of this wearable central line securement device can reduce line breaks, line dislodgment and line infections as compared to the traditional adhesive dressing. A secondary outcome for evaluation will be quality of life. This will be analyzed with a standardized quality of life survey and treatment effect will be reported as an ordinal odds ratio. Children are naturally active, however their activity is restricted by the parents given the delicate nature of their line. This study looks to see if quality of life can be improved a more secure wearable attachment device, as compared to traditional securement techniques.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-05
• Primary completion: 2022-09-15
• Completion: 2023-05-01
• First posted: 2020-08-21
• Last updated: 2024-07-05
• Results posted: 2024-07-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study