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    Summary
    EudraCT Number:2017-005169-33
    Sponsor's Protocol Code Number:CLEAN2
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-01-02
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2017-005169-33
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    A.3.2Name or abbreviated title of the trial where available
    CLEAN2
    A.4.1Sponsor's protocol code numberCLEAN2
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU DE POITIERS
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Poitiers
    B.5.2Functional name of contact pointABRIAT
    B.5.3 Address:
    B.5.3.1Street AddressDIRECTION DE LA RECHERCHE-2 RUE DE LA MILETRIE
    B.5.3.2Town/ cityPOITIERS
    B.5.3.4CountryFrance
    B.5.4Telephone number0549443796
    B.5.5Fax number0549443058
    B.5.6E-mailfanny.abriat@chu-poitiers.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ChloraPrep
    D.2.1.1.2Name of the Marketing Authorisation holderCAREFUSION U.K. 244 LTD
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCHLORAPREP
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Alcoholic Betadine
    D.2.1.1.2Name of the Marketing Authorisation holderMeda Pharma
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAlcoholic Betadine
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    surgery of the heart (valve, coronary or combined surgery) or of the aorta via a median sternotomy
    E.1.1.1Medical condition in easily understood language
    Surgery of the heart (valve, coronary or combined surgery) or of the aorta via a median sternotomy
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10048935
    E.1.2Term Open heart surgery
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10049052
    E.1.2Term Aortic surgery NOS
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that peri-operative skin preparation with 2% CHG-70% isopropanol decreases the rate of reoperation at any surgical site compared to peri-operative skin preparation with 5% PVI-69% ethanol.
    E.2.2Secondary objectives of the trial
    To compare the following items according to the peri-operative antiseptic strategy used
     Mediastinitis.
     Deep incisional SSI at saphen venous site.
     Superficial incisional SSI at both surgical sites.
     Reoperation for SWI.
     Reoperation for deep or superficial saphen venous SSI
     Pathogens involved in mediastinitis, deep and superficial SSI.
     Readmission to intensive care unit (ICU).
     Readmission to hospital
     Length of stay in ICU.
     Duration of mechanical ventilation.
     Length of Hospital stay.
     Length of stay in rehabilitation unit.
     Mortality.
     Safety.
     Costs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adult patients (age ≥ 18 years)
    • Undergoing any (scheduled or emergent) surgery of the heart (valve, coronary or combined surgery) or of the aorta via a median sternotomy
    • Having given their informed consent
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of any re-sternotomy occurring between Day 0 and Day 90 after surgery and/or any reoperation on saphen venous site occurring between Day 0 and Day 30 after surgery.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 30 or 90
    E.5.2Secondary end point(s)
     Incidence of mediastinitis according to CDC criteria occurring by Day 90 after surgery and pathogens involved.
     Incidence of deep incisional SSIs at saphen venous site, superficial incisional SSIs at sternal or saphen venous 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 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
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 30 or 90
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned13
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS+6 months for analysis
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months21
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 4000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    NONE
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
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