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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tissue adhesive | Experimental | 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). |
|
| Control group | No Intervention | Regular CLABSI preventive protocol. Regular preventive CVL dressings (Chlorhexidine >2mo). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-octyl cyanoacrylate based topical skin adhesive | Device | Tissue adhesive on CVL exit-site |
|
| Measure | Description | Time Frame |
|---|---|---|
| CLABSI rate | up to 1 year |
| 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 |
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Inclusion Criteria:
All patients admitted to pediatric cardiac ICU (PCICU) defined as high-risk for CLABSI (any of):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eran Shostak, MD | Contact | 972-3-9253114 | eransho@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Ovadia Dagan, Prof. M.D | Director PCICU, Schneider Children's Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider's children medical center | Recruiting | Petah Tikva | Israel |
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Prospective, randomized, open labeled study
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| 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 |