NCT05721677

CLABSI Prevention With Tissue Adhesive

The Impact of Central-line Exit-site Sealing With 2-octyl Cyanoacrylate Adhesive on CLABSI in Pediatric Cardiac Intensive Care Unit

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 0 Days – 18 Years
• Healthy volunteers: Not accepted

Summary

Our aim is to test the effect of tissue adhesive application at the Central-line exit-site on CLABSI rates in high-risk pediatric congenital heart disease patients.

Detailed description

Health-care associated infections (HAI) and especially central-line associated blood stream infections (CLABSI) are a well described burden in the intensive care units. There are two main possible pathways leading to central-venous line (CVL) related infection: the first is migration of microbes down the catheter tract (between the CVL and the skin), and the second is via the catheter hub/lumen. Cyanoacrylate adhesive is a commonly used tissue adhesive in children and adults with frequent use in pediatric facial lacerations. Several studies have shown its feasibility and safety in the general pediatric population, including neonates and in children after cardiac surgery. To our knowledge, no study to date has explored the use of 2-octyl cyanoacrylate at central-line exit site as a mean to decreases pediatric CLABSI. Our aim is to assess 2-octyl cyanoacrylate association with CLABSI rate in pediatric cardiac intensive care population.

Conditions

• Central-line Associated Blood Stream Infections (CLABSI)

Interventions

Type	Name	Description
DEVICE	2-octyl cyanoacrylate based topical skin adhesive	Tissue adhesive on CVL exit-site

Timeline

• Start date: 2023-03-15
• Primary completion: 2026-03-15
• Completion: 2026-09-15
• First posted: 2023-02-10
• Last updated: 2024-10-02

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated device study