CLABSI Prevention With Tissue Adhesive

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Central-line Associated Blood Stream Infections (CLABSI)

Intervention / Treatment
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* Device: 2-octyl cyanoacrylate based topical skin adhesive


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, open labeled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tissue adhesive<br>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<br>* Tissue adhesive on CVL exit-site<br>|
| No Intervention: Control group<br>Regular CLABSI preventive protocol. Regular preventive CVL dressings (Chlorhexidine >2mo). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| need for cardiopulmonary resuscitation (CPR) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CLABSI, Pediatric, Cardiac intensive care, cyanoacrylate, tissue adhesive