CLABSI Prevention With Tissue Adhesive
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-18
SponsorRabin Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with on-going bacteremia
patients with pre-existing central-line or peripherally inserted central catheter (PICC)
parental refusal to participate.
Trial design
Design model
Parallel
Treatments tested in this trial
2-octyl cyanoacrylate based topical skin adhesive
DeviceTissue adhesive on CVL exit-site
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Tissue adhesiveExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
CLABSI rate
Time frame
up to 1 yearSecondary outcomes
1
dressing changes rates
Time frame
average of 14 days2
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
Time frame
average of 14 days3
invasive mechanical ventilation duration
days
Time frame
up to 1 year4
ICU LOS
days
Time frame
up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov