CLABSI Prevention With Tissue Adhesive

Rabin Medical Center600 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

600

Conditions

Central-line Associated Blood Stream Infections (CLABSI)

Interventions

2-octyl cyanoacrylate based topical skin adhesiveDEVICE

Tissue adhesive on CVL exit-site

Eligibility

Sex: ALLMin age: 0 DaysMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Schneider's children medical center

Petah Tikva, Israel

RECRUITING

Outcomes

Primary Outcomes

CLABSI rate

Time frame: up to 1 year

Secondary Outcomes

dressing changes rates

Time frame: 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

Time frame: average of 14 days

invasive mechanical ventilation duration

days

Time frame: up to 1 year

ICU LOS

days

Time frame: up to 1 year

Postoperative ECMO support

Time frame: up to 1 year

Chylothorax

Time frame: up to 1 year

Chest drains duration

days

Time frame: up to 1 year

need for cardiopulmonary resuscitation (CPR)

Time frame: up to 1 year

Extubation failure

rate

Time frame: up to 1 year

Central Contacts

Eran Shostak, MD

CONTACT

972-3-9253114 eransho@clalit.org.il

Data from ClinicalTrials.gov

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