E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
surgery of the heart (valve, coronary or combined surgery) or of the aorta via a median sternotomy |
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E.1.1.1 | Medical condition in easily understood language |
Surgery of the heart (valve, coronary or combined surgery) or of the aorta via a median sternotomy |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048935 |
E.1.2 | Term | Open heart surgery |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049052 |
E.1.2 | Term | Aortic surgery NOS |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate that peri-operative skin preparation with 2% CHG-70% isopropanol decreases the rate of reoperation at any surgical site compared to peri-operative skin preparation with 5% PVI-69% ethanol. |
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E.2.2 | Secondary objectives of the trial |
To compare the following items according to the peri-operative antiseptic strategy used Mediastinitis. Deep incisional SSI at saphen venous site. Superficial incisional SSI at both surgical sites. Reoperation for SWI. Reoperation for deep or superficial saphen venous SSI Pathogens involved in mediastinitis, deep and superficial SSI. Readmission to intensive care unit (ICU). Readmission to hospital Length of stay in ICU. Duration of mechanical ventilation. Length of Hospital stay. Length of stay in rehabilitation unit. Mortality. Safety. Costs
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Adult patients (age ≥ 18 years) • Undergoing any (scheduled or emergent) surgery of the heart (valve, coronary or combined surgery) or of the aorta via a median sternotomy • Having given their informed consent |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of any re-sternotomy occurring between Day 0 and Day 90 after surgery and/or any reoperation on saphen venous site occurring between Day 0 and Day 30 after surgery. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Incidence of mediastinitis according to CDC criteria occurring by Day 90 after surgery and pathogens involved. Incidence of deep incisional SSIs at saphen venous site, superficial incisional SSIs at sternal or saphen venous sites according to CDC criteria occurring by Day 30 after surgery and pathogens involved. Incidence of SWI requiring reoperation, occurring by Day 90. Incidence of SSIs at saphen venous site requiring reoperation, occurring by Day 30. Incidence of unexpected need for re-admission to the ICU or re-hospitalisation. Number of days in ICU. Number of days under mechanical ventilation. Number of days in Hospital. Number of days in rehabilitation unit. Mortality at Day 90 of surgery. Incidence of local and systemic side effects possibly linked to antiseptic use. Economic analysis including cost-effectiveness of surgical skin antisepsis
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 13 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS+6 months for analysis |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 21 |
E.8.9.1 | In the Member State concerned days | |