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)
Primary Purpose
Cardiac Surgery in Adult Patient
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
2%Chlorhexidine-70%Isopropanol
5%Povidone Iodine- 69%Ethanol
Sponsored by
About this trial
This is an interventional prevention trial for Cardiac Surgery in Adult Patient focused on measuring Skin antisepsis, Chlorhexidine, Povidone Iodine, Surgical site infection
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.
Sites / Locations
- University Hospital of Clermont-Ferrand
- University Hospital of Nantes
- La Pitié Salpétrière Hospital
- Institut Mutualiste Montsouris
- University Hospital of Poitiers
- University Hospital of Rennes
- CHRU de Strasbourg
- CHU de Toulouse
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Chlorhexidine Group
Povidone Iodine Group
Arm Description
Outcomes
Primary Outcome Measures
Incidence of any re-sternotomy occurring between Day 0 and Day 90 after surgery
Incidence of any reoperation on saphen venous/radial artery site occurring between Day 0 and Day 30 after surgery.
Secondary Outcome Measures
Incidence of mediastinitis according to CDC criteria occurring by Day 90 after surgery and pathogens involved
Incidence of deep incisional SSIs at saphen venous/radial artery site according to CDC criteria occurring by Day 30 after surgery and pathogens involved
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
Incidence of SWI requiring reoperation, occurring by Day 90
Incidence of SSIs at saphen venous/radial artery site requiring reoperation, occurring by Day 30
Incidence of unexpected need for re-admission to the ICU or re-hospitalisation
Number of days in ICU
Number of days under mechanical ventilation
Number of days in Hospital
Number of days in rehabilitation unit
Mortality at Day 90 of surgery
Incidence of local and systemic side effects possibly linked to antiseptic use
Economic analysis including cost-effectiveness of surgical skin antisepsis
Full Information
NCT ID
NCT03560193
First Posted
May 24, 2018
Last Updated
June 10, 2022
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03560193
Brief Title
Randomized Trial of 2% Chlorhexidine-70% Isopropanol vs 5% Povidone Iodine-69% Ethanol for Skin Antisepsis in Reducing Surgical-site Infection After Cardiac Surgery
Acronym
CLEAN2
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
May 25, 2022 (Actual)
Study Completion Date
May 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery in Adult Patient
Keywords
Skin antisepsis, Chlorhexidine, Povidone Iodine, Surgical site infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3316 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chlorhexidine Group
Arm Type
Experimental
Arm Title
Povidone Iodine Group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
2%Chlorhexidine-70%Isopropanol
Intervention Description
2% Chlorhexidine-70% isopropanol will be used to disinfect the skin before Cardiac Surgery and during all dressing changes
Intervention Type
Drug
Intervention Name(s)
5%Povidone Iodine- 69%Ethanol
Intervention Description
5%Povidone Iodine- 69%Ethanol will be used to disinfect the skin before Cardiac Surgery and during all dressing changes
Primary Outcome Measure Information:
Title
Incidence of any re-sternotomy occurring between Day 0 and Day 90 after surgery
Time Frame
90 days
Title
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 Measure Information:
Title
Incidence of mediastinitis according to CDC criteria occurring by Day 90 after surgery and pathogens involved
Time Frame
90 days
Title
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
Title
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
Title
Incidence of SWI requiring reoperation, occurring by Day 90
Time Frame
90 days
Title
Incidence of SSIs at saphen venous/radial artery site requiring reoperation, occurring by Day 30
Time Frame
30 days
Title
Incidence of unexpected need for re-admission to the ICU or re-hospitalisation
Time Frame
90 days
Title
Number of days in ICU
Time Frame
90 days
Title
Number of days under mechanical ventilation
Time Frame
90 days
Title
Number of days in Hospital
Time Frame
90 days
Title
Number of days in rehabilitation unit
Time Frame
90 days
Title
Mortality at Day 90 of surgery
Time Frame
90 days
Title
Incidence of local and systemic side effects possibly linked to antiseptic use
Time Frame
90 days
Title
Economic analysis including cost-effectiveness of surgical skin antisepsis
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University Hospital of Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63100
Country
France
Facility Name
University Hospital of Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
La Pitié Salpétrière Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
University Hospital of Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
University Hospital of Rennes
City
Rennes
Country
France
Facility Name
CHRU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31400
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
31213447
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.
Results Reference
derived
Learn more about this trial
Randomized Trial of 2% Chlorhexidine-70% Isopropanol vs 5% Povidone Iodine-69% Ethanol for Skin Antisepsis in Reducing Surgical-site Infection After Cardiac Surgery
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