Central-line Associated Blood Stream Infections (CLABSI)Cya-No-CLABSINCT05721677
CLABSI Prevention With Tissue Adhesive
A study testing 2-octyl cyanoacrylate based topical skin adhesive in people with Central-line Associated Blood Stream Infections (CLABSI), run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 18 years
- Conditions the study is for
- Central-line Associated Blood Stream Infections (CLABSI)
- What is being tested?
- 2-octyl cyanoacrylate based topical skin adhesive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Mar 2023to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patients with on-going bacteremia
- patients with pre-existing central-line or peripherally inserted central catheter (PICC)
- parental refusal to participate.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Schneider's children medical center
Petah Tikva
Eran Shostak, MD, 972-3-9253114, eransho@clalit.org.il
Ofer Schiller, M.D
About this study
Official title: The Impact of Central-line Exit-site Sealing With 2-octyl Cyanoacrylate Adhesive on CLABSI in Pediatric Cardiac Intensive Care Unit
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.
Read the 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.
- Being tested
- 2-octyl cyanoacrylate based topical skin adhesive
- Keywords
- CLABSI, Pediatric, Cardiac intensive care, cyanoacrylate, tissue adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-octyl cyanoacrylate based topical skin adhesiveDevice
Tissue adhesive on CVL exit-site
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: 2-octyl cyanoacrylate based topical skin adhesive |
| Control group | No intervention | Regular CLABSI preventive protocol. Regular preventive CVL dressings (Chlorhexidine >2mo). |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLABSI rate
Measured: up to 1 year
Secondary outcomes (12)
dressing changes rates
Measured: 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
Measured: average of 14 days
invasive mechanical ventilation duration
days
Measured: up to 1 year
ICU LOS
days
Measured: up to 1 year
Postoperative ECMO support
Measured: up to 1 year
Chylothorax
Measured: up to 1 year
Chest drains duration
days
Measured: up to 1 year
need for cardiopulmonary resuscitation (CPR)
Measured: up to 1 year
Extubation failure
rate
Measured: up to 1 year
presence of lung atelectasis
Measured: up to 1 year
multidrug resistant bacterial colonization
Measured: up to 1 year
mortality rate
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start15 Mar 2023
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central-line Associated Blood Stream Infections (CLABSI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, open labeled study
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ERAN SHOSTAK, Rabin Medical Center
- Investigators
- Ovadia Dagan, Prof. M.D, Study director, Director PCICU, Schneider Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721677
- Sponsor's protocol ID
- RMC220375CTIL
- Acronym
- Cya-No-CLABSI
- Status last verified
- Sep 2024
- First submitted
- 17 Jan 2023
- Last updated
- 2 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Central-line Exit-site Sealing With 2-octyl Cyanoacrylate Adhesive on CLABSI in Pediatric Cardiac Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05721677
- Acronym / sponsor ID
- Cya-No-CLABSI / RMC220375CTIL
- Keywords
- CLABSI, Pediatric, Cardiac intensive care, cyanoacrylate, tissue adhesive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, open labeled study
| Arm | Type | Receives |
|---|---|---|
| Tissue adhesive | Experimental | Device: 2-octyl cyanoacrylate based topical skin adhesiveTissue 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). |
Who may qualify
- Ages
- 0 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with on-going bacteremia
- patients with pre-existing central-line or peripherally inserted central catheter (PICC)
- parental refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-octyl cyanoacrylate based topical skin adhesiveTissue adhesive on CVL exit-site | Device | Tissue adhesive |
Primary outcome
CLABSI rate
Time frame: up to 1 year
12 secondary outcomes
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
Time frame: average of 14 days
invasive mechanical ventilation duration
Time frame: up to 1 year
ICU LOS
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
Time frame: up to 1 year
need for cardiopulmonary resuscitation (CPR)
Time frame: up to 1 year
Extubation failure
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ovadia Dagan, Prof. M.D study director
Director PCICU, Schneider Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-octyl cyanoacrylate based topical skin adhesive in people with Central-line Associated Blood Stream Infections (CLABSI), run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eran Shostak, MD (972-3-9253114, eransho@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CLABSI rate (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.