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
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
1 other identifier
interventional
3,316
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2018
Longer than P75 for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2018
CompletedFirst Posted
Study publicly available on registry
June 18, 2018
CompletedStudy Start
First participant enrolled
September 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2022
CompletedJune 13, 2022
June 1, 2022
3.7 years
May 24, 2018
June 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of any re-sternotomy occurring between Day 0 and Day 90 after surgery
90 days
Incidence of any reoperation on saphen venous/radial artery site occurring between Day 0 and Day 30 after surgery.
30 days
Secondary Outcomes (13)
Incidence of mediastinitis according to CDC criteria occurring by Day 90 after surgery and pathogens involved
90 days
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
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
Incidence of SWI requiring reoperation, occurring by Day 90
90 days
Incidence of SSIs at saphen venous/radial artery site requiring reoperation, occurring by Day 30
30 days
- +8 more secondary outcomes
Study Arms (2)
Chlorhexidine Group
EXPERIMENTALPovidone Iodine Group
ACTIVE COMPARATORInterventions
2% Chlorhexidine-70% isopropanol will be used to disinfect the skin before Cardiac Surgery and during all dressing changes
5%Povidone Iodine- 69%Ethanol will be used to disinfect the skin before Cardiac Surgery and during all dressing changes
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
University Hospital of Clermont-Ferrand
Clermont-Ferrand, 63100, France
University Hospital of Nantes
Nantes, 44000, France
La Pitié Salpétrière Hospital
Paris, 75013, France
Institut Mutualiste Montsouris
Paris, 75014, France
University Hospital of Poitiers
Poitiers, 86021, France
University Hospital of Rennes
Rennes, France
CHRU de Strasbourg
Strasbourg, 67091, France
CHU de Toulouse
Toulouse, 31400, France
Related Publications (1)
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.
PMID: 31213447DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2018
First Posted
June 18, 2018
Study Start
September 10, 2018
Primary Completion
May 25, 2022
Study Completion
May 25, 2022
Last Updated
June 13, 2022
Record last verified: 2022-06