An open label, multicenter, randomized trial of 2% chlorhexidine-70% isopropanol vs 5% povidone iodine-69% ethanol for skin antisepsis in reducing surgical-site infection after cardiac surgery

An open label, multicenter, randomized trial of 2% chlorhexidine-70% isopropanol vs 5% povidone iodine-69% ethanol for skin antisepsis in reducing surgical-site infection after cardiac surgery - CLEAN2

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-005169-33-FR

Enrollment

4100

Registered

2018-01-02

Start date

2018-02-23

Completion date

Unknown

Last updated

2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

surgery of the heart (valve, coronary or combined surgery) or of the aorta via a median sternotomy MedDRA version: 20.0 Level: LLT Classification code 10048935 Term: Open heart surgery System Organ Class: 100000004865 MedDRA version: 20.0 Level: LLT Classification code 10049052 Term: Aortic surgery NOS System Organ Class: 100000004865

Interventions

Trade Name: ChloraPrep Product Name: CHLORAPREP Pharmaceutical Form: Cutaneous solution Trade Name: Alcoholic Betadine Product Name: Alcoholic Betadine Pharmaceutical Form: Cutaneous solution

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: 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 ;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.;Timepoint(s) of evaluation of this end point: Day 30 or 90	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: 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 ;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.;Timepoint(s) of evaluation of this end point: Day 30 or 90

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Secondary

Measure	Time frame
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 ;Timepoint(s) of evaluation of this end point: Day 30 or 90	—

Measure

Time frame

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 ;Timepoint(s) of evaluation of this end point: Day 30 or 90

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Countries

France

Contacts

Public ContactABRIAT

CHU de Poitiers

fanny.abriat@chu-poitiers.fr0549443796

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 21, 2026