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)

• ClinicalTrials.gov Identifier: NCT03560193
• Recruitment Status: Active, not recruiting
• First Posted: June 18, 2018
• Last Update Posted: January 4, 2022
• Sponsor: Poitiers University Hospital
• Information provided by (Responsible Party): Poitiers University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiac Surgery in Adult Patient	Drug: 2%Chlorhexidine-70%Isopropanol; Drug: 5%Povidone Iodine- 69%Ethanol	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3316 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: September 10, 2018
• Estimated Primary Completion Date: May 2022
• Estimated Study Completion Date: May 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Chlorhexidine Group	Drug: 2%Chlorhexidine-70%Isopropanol; 2% Chlorhexidine-70% isopropanol will be used to disinfect the skin before Cardiac Surgery and during all dressing changes
Active Comparator: Povidone Iodine Group	Drug: 5%Povidone Iodine- 69%Ethanol; 5%Povidone Iodine- 69%Ethanol will be used to disinfect the skin before Cardiac Surgery and during all dressing changes

Outcome Measures

Primary Outcome Measures :

1. Incidence of any re-sternotomy occurring between Day 0 and Day 90 after surgery [ Time Frame: 90 days ]
2. Incidence of any reoperation on saphen venous/radial artery site occurring between Day 0 and Day 30 after surgery. [ Time Frame: 30 days ]

Secondary Outcome Measures :

1. Incidence of mediastinitis according to CDC criteria occurring by Day 90 after surgery and pathogens involved [ Time Frame: 90 days ]
2. Incidence of deep incisional SSIs at saphen venous/radial artery site according to CDC criteria occurring by Day 30 after surgery and pathogens involved [ Time Frame: 30 days ]
3. 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 [ Time Frame: 30 days ]
4. Incidence of SWI requiring reoperation, occurring by Day 90 [ Time Frame: 90 days ]
5. Incidence of SSIs at saphen venous/radial artery site requiring reoperation, occurring by Day 30 [ Time Frame: 30 days ]
6. Incidence of unexpected need for re-admission to the ICU or re-hospitalisation [ Time Frame: 90 days ]
7. Number of days in ICU [ Time Frame: 90 days ]
8. Number of days under mechanical ventilation [ Time Frame: 90 days ]
9. Number of days in Hospital [ Time Frame: 90 days ]
10. Number of days in rehabilitation unit [ Time Frame: 90 days ]
11. Mortality at Day 90 of surgery [ Time Frame: 90 days ]
12. Incidence of local and systemic side effects possibly linked to antiseptic use [ Time Frame: 90 days ]
13. Economic analysis including cost-effectiveness of surgical skin antisepsis [ Time Frame: 90 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

France

University Hospital of Clermont-Ferrand

Clermont-Ferrand, France, 63100

University Hospital of Nantes

Nantes, France, 44000

La Pitié Salpétrière Hospital

Paris, France, 75013

Institut Mutualiste Montsouris

Paris, France, 75014

University Hospital of Poitiers

Poitiers, France, 86021

University Hospital of Rennes

Rennes, France

CHRU de Strasbourg

Strasbourg, France, 67091

CHU de Toulouse

Toulouse, France, 31400

Sponsors and Collaborators

Poitiers University Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Poitiers University Hospital
• ClinicalTrials.gov Identifier: NCT03560193
• Other Study ID Numbers: CLEAN2
• First Posted: June 18, 2018
• Last Update Posted: January 4, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Poitiers University Hospital:

Skin antisepsis; Chlorhexidine; Povidone Iodine; Surgical site infection

Additional relevant MeSH terms:

Infections; Surgical Wound Infection; Wound Infection; Postoperative Complications; Pathologic Processes; Chlorhexidine; Ethanol; Povidone-Iodine; Povidone; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Central Nervous System Depressants; Physiological Effects of Drugs; Plasma Substitutes; Blood Substitutes