CLABSI Prevention With Tissue Adhesive (Cya-No-CLABSI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Central-line Associated Blood Stream Infections (CLABSI)
• Intervention / Treatment: Device: 2-octyl cyanoacrylate based topical skin adhesive

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eran Shostak, MD; Phone Number: 972-3-9253114; Email: eransho@clalit.org.il

Study Locations

• Israel
  • Petach tikva, Israel
    • Recruiting
    • Schneider's children medical center
    • Sub-Investigator: Ofer Schiller, M.D
    • Contact: Eran Shostak, MD; Phone Number: 972-3-9253114; Email: eransho@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

All patients admitted to pediatric cardiac ICU (PCICU) defined as high-risk for CLABSI (any of):

• young age<1y & Congenital Heart Surgery Mortality Category (STAT\STS-EACTS) score 2-5
• Risk Adjustment for Congenital Heart Surgery (RACHS) category ≥3
• preoperative length-of-stay (LOS) >7 days
• preoperative ventilator support
• presence of a genetic abnormality
• extracorporeal membrane oxygenation (ECMO) support

Exclusion Criteria:

• Patients with on-going bacteremia
• patients with pre-existing central-line or peripherally inserted central catheter (PICC)
• parental refusal to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tissue adhesive; Tissue adhesive application at the CVL exit-site, on all CVLs, PICCs during the patient LOS. Regular CLABSI preventive protocol. Regular preventive CVL dressings (Chlorhexidine >2mo).	Device: 2-octyl cyanoacrylate based topical skin adhesive; Tissue adhesive on CVL exit-site
No Intervention: Control group; Regular CLABSI preventive protocol. Regular preventive CVL dressings (Chlorhexidine >2mo).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CLABSI rate	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dressing changes rates		average of 14 days
safety outcome: Number pf participants with contact dermatitis at the catheter exit site, line dislodgement, leak, exit site bleeding, allergic reaction or line tunnel infection	number of patients suffering from contact dermatitis at the catheter exit site, line dislodgement, leak, exit site bleeding, allergic reaction or line tunnel infection	average of 14 days
invasive mechanical ventilation duration	days	up to 1 year
ICU LOS	days	up to 1 year
Postoperative ECMO support		up to 1 year
Chylothorax		up to 1 year
Chest drains duration	days	up to 1 year
Extubation failure	rate	up to 1 year
presence of lung atelectasis		up to 1 year
multidrug resistant bacterial colonization		up to 1 year
mortality rate		up to 1 year
need for cardiopulmonary resuscitation (CPR)		up to 1 year

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Study Director: Ovadia Dagan, Prof. M.D, Director PCICU, Schneider Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Estimated): March 15, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric; tissue adhesive; cyanoacrylate; CLABSI; Cardiac intensive care
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: RMC220375CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes