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CLABSI Prevention With Tissue Adhesive (Cya-No-CLABSI)

Primary Purpose

Central-line Associated Blood Stream Infections (CLABSI)

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
2-octyl cyanoacrylate based topical skin adhesive
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Central-line Associated Blood Stream Infections (CLABSI) focused on measuring CLABSI, Pediatric, Cardiac intensive care, cyanoacrylate, tissue adhesive

Eligibility Criteria

0 Days - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Schneider's children medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tissue adhesive

Control group

Arm Description

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).

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

Outcomes

Primary Outcome Measures

CLABSI rate

Secondary Outcome Measures

dressing changes rates
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
invasive mechanical ventilation duration
days
ICU LOS
days
Postoperative ECMO support
Chylothorax
Chest drains duration
days
need for cardiopulmonary resuscitation (CPR)
Extubation failure
rate
presence of lung atelectasis
multidrug resistant bacterial colonization
mortality rate

Full Information

First Posted
January 17, 2023
Last Updated
April 4, 2023
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05721677
Brief Title
CLABSI Prevention With Tissue Adhesive
Acronym
Cya-No-CLABSI
Official Title
The Impact of Central-line Exit-site Sealing With 2-octyl Cyanoacrylate Adhesive on CLABSI in Pediatric Cardiac Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
March 15, 2026 (Anticipated)
Study Completion Date
September 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central-line Associated Blood Stream Infections (CLABSI)
Keywords
CLABSI, Pediatric, Cardiac intensive care, cyanoacrylate, tissue adhesive

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, open labeled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tissue adhesive
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Regular CLABSI preventive protocol. Regular preventive CVL dressings (Chlorhexidine >2mo).
Intervention Type
Device
Intervention Name(s)
2-octyl cyanoacrylate based topical skin adhesive
Intervention Description
Tissue adhesive on CVL exit-site
Primary Outcome Measure Information:
Title
CLABSI rate
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
dressing changes rates
Time Frame
average of 14 days
Title
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
Description
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
Title
invasive mechanical ventilation duration
Description
days
Time Frame
up to 1 year
Title
ICU LOS
Description
days
Time Frame
up to 1 year
Title
Postoperative ECMO support
Time Frame
up to 1 year
Title
Chylothorax
Time Frame
up to 1 year
Title
Chest drains duration
Description
days
Time Frame
up to 1 year
Title
need for cardiopulmonary resuscitation (CPR)
Time Frame
up to 1 year
Title
Extubation failure
Description
rate
Time Frame
up to 1 year
Title
presence of lung atelectasis
Time Frame
up to 1 year
Title
multidrug resistant bacterial colonization
Time Frame
up to 1 year
Title
mortality rate
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eran Shostak, MD
Phone
972-3-9253114
Email
eransho@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ovadia Dagan, Prof. M.D
Organizational Affiliation
Director PCICU, Schneider Children's Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Schneider's children medical center
City
Petach tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eran Shostak, MD
Phone
972-3-9253114
Email
eransho@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Ofer Schiller, M.D

12. IPD Sharing Statement

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CLABSI Prevention With Tissue Adhesive

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