Cardiac Surgery in Adult Patient Clinical Trial
— CLEAN2Official 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
| Verified date | June 2022 |
| Source | Poitiers University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 3316 |
| Est. completion date | May 25, 2022 |
| Est. primary completion date | May 25, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital of Clermont-Ferrand | Clermont-Ferrand | |
| France | University Hospital of Nantes | Nantes | |
| France | Institut Mutualiste Montsouris | Paris | |
| France | La Pitié Salpétrière Hospital | Paris | |
| France | University Hospital of Poitiers | Poitiers | |
| France | University Hospital of Rennes | Rennes | |
| France | CHRU de Strasbourg | Strasbourg | |
| France | CHU de Toulouse | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| Poitiers University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of any re-sternotomy occurring between Day 0 and Day 90 after surgery | 90 days | ||
| Primary | Incidence of any reoperation on saphen venous/radial artery site occurring between Day 0 and Day 30 after surgery. | 30 days | ||
| Secondary | Incidence of mediastinitis according to CDC criteria occurring by Day 90 after surgery and pathogens involved | 90 days | ||
| Secondary | Incidence of deep incisional SSIs at saphen venous/radial artery site according to CDC criteria occurring by Day 30 after surgery and pathogens involved | 30 days | ||
| Secondary | 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 | 30 days | ||
| Secondary | Incidence of SWI requiring reoperation, occurring by Day 90 | 90 days | ||
| Secondary | Incidence of SSIs at saphen venous/radial artery site requiring reoperation, occurring by Day 30 | 30 days | ||
| Secondary | Incidence of unexpected need for re-admission to the ICU or re-hospitalisation | 90 days | ||
| Secondary | Number of days in ICU | 90 days | ||
| Secondary | Number of days under mechanical ventilation | 90 days | ||
| Secondary | Number of days in Hospital | 90 days | ||
| Secondary | Number of days in rehabilitation unit | 90 days | ||
| Secondary | Mortality at Day 90 of surgery | 90 days | ||
| Secondary | Incidence of local and systemic side effects possibly linked to antiseptic use | 90 days | ||
| Secondary | Economic analysis including cost-effectiveness of surgical skin antisepsis | 90 days |