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)

Poitiers University Hospital

Status and phase

Completed

Phase 4

Conditions

Cardiac Surgery in Adult Patient

Treatments

Drug: 5%Povidone Iodine- 69%Ethanol

Drug: 2%Chlorhexidine-70%Isopropanol

Study type

Interventional

Funder types

Other

Identifiers

NCT03560193

CLEAN2

Details and patient eligibility

About

Despite completion of more than 9 million procedures each year in France, the best antiseptic solution to be used for preparing the skin to reduce risk of surgical site infection (SSI) remains unknown. 2% Chlorhexidine gluconate (CHG)-alcohol is superior to Povidone Iodine (PVI)-alcohol for short term vascular catheter care (Mimoz O, Lancet 2015; Pages J, Intensive Care Med 2016), but studies comparing both antiseptic solutions for clean-contaminated surgical procedures led to conflicting results.

The present study will be the first large scale multicenter randomized controlled trial adequately powered to compare efficacy and safety of CHG-alcohol over PVI-alcohol in reducing SSI after clean surgery.

A clean surgery was chosen because pathogens involved in SSI mostly originate from skin. Therefore, optimisation of skin disinfection before surgery has the potential to reduce the incidence of SSI. Cardiac surgery was chosen because SSI may be severe, diagnosis of SSI is easy to monitor and to define and infections arise earlier than other frequent clean surgeries using implants such as orthopaedic or vascular surgery.

The incidence of reoperation for any purpose will be used as the main objective because there are easy to track and define and are less susceptible to interpretation in an open trial than superficial SSI. According to CDC criteria, patients will be monitored up to Day 90 because mediastinitis after cardiac surgery may occur after the usual 30-day SSI surveillance period.

Enrollment

3,316 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.