Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 1:21 AM
NCT ID:
NCT03560193
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (age ≥ 18 years)
* Undergoing any (scheduled) surgery of the heart (valve, coronary or combined surgery) or of the aorta via a median sternotomy
* Having given their informed consent
Exclusion Criteria:
* Patients with known allergies to CHG, PVI, isopropanol or ethanol
* Surgery for heart transplantation
* Any signs of inflammation or sternal instability at the site of sternotomy or operation for infection (SWI or endocarditis)
* Patients with history of cardiac surgery within 3 months preceding enrolment
* Participation to another clinical trial aimed at reducing SSI
* Patients already enrolled in this study
* Pregnant or breastfeeding women
* Women at age to procreate and not using effective contraception
* Patients not benefiting from a Social Security scheme or not benefiting from it through a third party
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03560193
Study Brief:
Protocol Section:
NCT03560193