An interventional study of 2-octyl cyanoacrylate based topical skin adhesive in Central-line Associated Blood Stream Infections (CLABSI), sponsored by Rabin Medical Center. Status unknown at 1 site in Israel. Open to participants aged 0 Days to 18 Years. Per ClinicalTrials.gov, last updated 2024-10-02.
Sponsored by Rabin Medical Center · Not applicable, Interventional, and Prevention
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.
Rabin Medical Center is the lead sponsor of 393 studies on the registry; 30 are open to participants now.
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All patients admitted to pediatric cardiac ICU (PCICU) defined as high-risk for CLABSI (any of):
Exclusion Criteria:
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
Regular CLABSI preventive protocol. Regular preventive CVL dressings (Chlorhexidine \>2mo).
Tissue adhesive on CVL exit-site
CLABSI rate
Time frame: up to 1 year
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
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
This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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