CLABSI Prevention With Tissue Adhesive

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2026-09-15

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.

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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.

Conditions

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Central-line Associated Blood Stream Infections (CLABSI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, open labeled study

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Tissue adhesive

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).

Group Type EXPERIMENTAL

2-octyl cyanoacrylate based topical skin adhesive

Intervention Type DEVICE

Tissue adhesive on CVL exit-site

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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2-octyl cyanoacrylate based topical skin adhesive

Tissue adhesive on CVL exit-site

Intervention Type DEVICE

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.

Minimum Eligible Age

0 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No