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

Clalit Health Services

Status: Enrolling

Conditions: Central-line Associated Blood Stream Infections (CLABSI)

Treatments: Device: 2-octyl cyanoacrylate based topical skin adhesive

Study type: Interventional

Funder types: Other

Identifiers

NCT05721677

RMC220375CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Tissue adhesive

Experimental group

Description:

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).

Treatment:

Device: 2-octyl cyanoacrylate based topical skin adhesive

Control group

No Intervention group

Description:

Regular CLABSI preventive protocol. Regular preventive CVL dressings (Chlorhexidine \>2mo).