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Recruiting

NCT Number: NCT05721677

CLABSI Prevention With Tissue Adhesive

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.

Recruiting

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Key information

Age range

0 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schneider's children medical center

Petah Tikva, Israel

Location status: Recruiting

Location contact

Eran Shostak, MD

CONTACT

[email protected]

972-3-9253114

Ofer Schiller, M.D

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

2-octyl cyanoacrylate based topical skin adhesive

Device

Tissue adhesive on CVL exit-site

Primary outcomes

  1. CLABSI rate

    Time frame: up to 1 year

Secondary outcomes

  1. dressing changes rates

    Time frame: average of 14 days

  2. 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

    number of patients suffering from contact dermatitis at the catheter exit site, line dislodgement, leak, exit site bleeding, allergic reaction or line tunnel infection

  3. invasive mechanical ventilation duration

    Time frame: up to 1 year

    days

  4. ICU LOS

    Time frame: up to 1 year

    days

  5. Postoperative ECMO support

    Time frame: up to 1 year

  6. Chylothorax

    Time frame: up to 1 year

  7. Chest drains duration

    Time frame: up to 1 year

    days

  8. need for cardiopulmonary resuscitation (CPR)

    Time frame: up to 1 year

  9. Extubation failure

    Time frame: up to 1 year

    rate

  10. presence of lung atelectasis

    Time frame: up to 1 year

  11. multidrug resistant bacterial colonization

    Time frame: up to 1 year

  12. mortality rate

    Time frame: up to 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Eran Shostak, MD

CONTACT

[email protected]

972-3-9253114

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

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

Acronym: Cya-No-CLABSI

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2023
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.