CLABSI Prevention With Tissue Adhesive
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 2-octyl cyanoacrylate based topical skin adhesive.
- Who it may be relevant to
- Registry conditions: Central-line Associated Blood Stream Infections (CLABSI). Basic parameters: 0 Days — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Impact of Central-line Exit-site Sealing With 2-octyl Cyanoacrylate Adhesive on CLABSI in Pediatric Cardiac Intensive Care Unit
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.
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.
Interventions
- Device 2-octyl cyanoacrylate based topical skin adhesive
Tissue adhesive on CVL exit-site
Primary outcome measures
- CLABSI rate [Time frame: up to 1 year]
Secondary outcome measures (12)
- 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 [Time frame: average of 14 days]
- invasive mechanical ventilation duration [Time frame: up to 1 year]
- ICU LOS [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 [Time frame: up to 1 year]
- need for cardiopulmonary resuscitation (CPR) [Time frame: up to 1 year]
- Extubation failure [Time frame: up to 1 year]
- presence of lung atelectasis [Time frame: up to 1 year]
- multidrug resistant bacterial colonization [Time frame: up to 1 year]
- mortality rate [Time frame: up to 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Israel · 1 center
- Schneider's children medical center — Petah Tikva
Identifiers
NCT: NCT05721677 · RMC220375CTIL