Clinical trial NCT03560193: Randomized Trial of 2% Chlorhexidine-70% Isopropanol vs 5% Povidone Iodine-69% Ethanol for Skin Antisepsis in Reducing Surgical-site Infection After Cardiac Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Surgery in Adult Patient
Keywords: Skin antisepsis
Chlorhexidine
Povidone Iodine
Surgical site infection
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 3316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


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.

Primary outcomes:
measure: Incidence of any re-sternotomy occurring between Day 0 and Day 90 after surgery
timeFrame: 90 days
measure: Incidence of any reoperation on saphen venous/radial artery site occurring between Day 0 and Day 30 after surgery.
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of mediastinitis according to CDC criteria occurring by Day 90 after surgery and pathogens involved
timeFrame: 90 days
measure: Incidence of deep incisional SSIs at saphen venous/radial artery site according to CDC criteria occurring by Day 30 after surgery and pathogens involved
timeFrame: 30 days
measure: Incidence of superficial incisional SSIs at sternal or saphen venous/radial artery sites according to CDC criteria occurring by Day 30 after surgery and pathogens involved
timeFrame: 30 days
measure: Incidence of SWI requiring reoperation, occurring by Day 90
timeFrame: 90 days
measure: Incidence of SSIs at saphen venous/radial artery site requiring reoperation, occurring by Day 30
timeFrame: 30 days
measure: Incidence of unexpected need for re-admission to the ICU or re-hospitalisation
timeFrame: 90 days
measure: Number of days in ICU
timeFrame: 90 days
measure: Number of days under mechanical ventilation
timeFrame: 90 days
measure: Number of days in Hospital
timeFrame: 90 days
measure: Number of days in rehabilitation unit
timeFrame: 90 days
measure: Mortality at Day 90 of surgery
timeFrame: 90 days
measure: Incidence of local and systemic side effects possibly linked to antiseptic use
timeFrame: 90 days
measure: Economic analysis including cost-effectiveness of surgical skin antisepsis
timeFrame: 90 days
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: University Hospital of Clermont-Ferrand
city: Nantes
country: France
facility: University Hospital of Nantes
city: Paris
country: France
facility: La Pitié Salpétrière Hospital
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Poitiers
country: France
facility: University Hospital of Poitiers
city: Rennes
country: France
facility: University Hospital of Rennes
city: Strasbourg
country: France
facility: CHRU de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
References:
citation: Boisson M, Corbi P, Kerforne T, Camilleri L, Debauchez M, Demondion P, Eljezi V, Flecher E, Lepelletier D, Leprince P, Nesseler N, Nizou JY, Roussel JC, Rozec B, Ruckly S, Lucet JC, Timsit JF, Mimoz O. Multicentre, open-label, randomised, controlled clinical trial comparing 2% chlorhexidine-70% isopropanol and 5% povidone iodine-69% ethanol for skin antisepsis in reducing surgical-site infection after cardiac surgery: the CLEAN 2 study protocol. BMJ Open. 2019 Jun 17;9(6):e026929. doi: 10.1136/bmjopen-2018-026929.