Comparison of Alcoholic Chlorhexidine 2% Versus Alcoholic Povidone Iodine for Infections Prevention With Cardiac Resynchronization Therapy Device Implantation (CHLOVIS)

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Recruitment Status : Recruiting
First Posted : April 26, 2013
Last Update Posted : March 29, 2018
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:
Heart Failure (HF) with systolic dysfunction is associated with a poor prognosis in the long term despite the use of many effective drug treatment in reducing morbidity and mortality. In this context, cardiac resynchronization (CR), either alone or combined with a defibrillator function, has improved by about 30 to 40% of morbidity and mortality in this population of patients with heart failure. The information on the CR are now well established for patients with stage III-IV NYHA (New York Heart Association), with systolic dysfunction (EF ≤ 35%), presence of left bundle branch block wide (≥ 120 ms) and when medical treatment is optimal. As a result, the number of implanted devices continue to grow even if the implant procedures of cardiac resynchronization devices (CRD) are long, difficult and associated with significant complications with a risk of reoperation estimated between 10 and 15% . One of the most feared during implantation devices stimulation or defibrillation risk is represented by the risk of infection that will lead inevitably to explantation of the device. Despite the use of several preventive measures, including the use of an antiseptic shower, a local preparation for alcoholic povidone iodine (API) (PVPI 5% ethanol + 70%) and antibiotic prophylaxis clinical studies the most recent have clearly demonstrated that the risk of infection was associated with the duration of the intervention and was higher for procedures CR, it is noted in 2.4% in the short term and would be close to 3 to 4% in the medium term. Infections of implantable devices are associated with a poor prognosis, even in an excess mortality. It has been shown that the majority of infections may be linked to local contamination during surgery reinforcing the idea that prevention is mainly based on local measures and the reduction of operating time.

Condition or disease Intervention/treatment Phase
Heart Failure Arrhythmia Drug: alcoholic povidone iodine Drug: alcoholic chlorhexidine Phase 4

Detailed Description:
In this context, all measures that will reduce the risk of infection, will improve the prognosis of these patients. Thus, recent studies have shown greater effectiveness of local preparation for alcoholic chlorhexidine (applicator containing 2% chlorhexidine and 70% alcohol isopropanolol) (AC 2%) compared to the aqueous povidone iodine (API)in general surgery. It has been shown that the rate of local infection was significantly reduced in the AC group vs 2%. aqueous povidone iodine, respectively vs. 9.5%. 16.1% (p = 0.004). No randomized trials have previously prospectively compared the interest of local preparation with AC 2% compared with the usual preparation by API during implantation Resynchronization devices. Based on experimental and clinical studies, and we hope this new approach to assess local skin preparation in the prevention of general and local risk of infection after implantation of a cardiac resynchronization device. To ensure consistency, and because of its high efficiency assumed on the basis of experimental and clinical studies, the choice fell on the revenue 2% with applicator and patients should benefit from a primary location or "up-grading" to a CR device.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 randomized groups
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Alcoholic Chlorhexidine 2% Versus Alcoholic Povidone Iodine for Infections Prevention With Cardiac Resynchronization Therapy Device Implantation
Actual Study Start Date : April 23, 2013
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Arm Intervention/treatment
Active Comparator: alcoholic povidone iodine
Betadine Alcoolique 5% One cutaneous application before implant procedure
Drug: alcoholic povidone iodine
Other Name: Betadine alcoolique 5%

Experimental: alcoholic chlorhexidine
ChloraPrep 2% One cutaneous application before implant procedure
Drug: alcoholic chlorhexidine
Other Name: ChloraPrep 2%

Primary Outcome Measures :
  1. Infection [ Time Frame: 24 months ]
    Local or general infection in relation to the implantable device (skin erosion, externalization, local flow, local abscess, sepsis with or without bacteremia)

Secondary Outcome Measures :
  1. Cardiovascular event [ Time Frame: 24 months ]
    Major cardiovascular events such as heart failure, embolic right heart.

  2. Side Effects [ Time Frame: 24 months ]
    Side effects attributable to local treatment.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients requiring cardiac resynchronization therapy (stage III-IV NYHA, EF ≤ 35%, left bundle branch block large (≥ 120 ms), optimal medical therapy) OR patients requiring the implementation of a resynchronization device on basis of the study PAVE (FE ≤ 45% + Atrial Fibrillation + need a radiofrequency atrioventricular node) OR patients requiring implantable pacemaker or implantable defibrillator but NYHA stage II, EF ≤ 35%; branch block left large (≥ 150 ms) optimal medical treatment OR patient requiring an upgrading at least 2 years after their last implementation
  • Patient has consented free, informed
  • Patients whose prognosis is not compromised by a morbid pathology in one year
  • absence of contraindication to povidone-iodine alcoholic
  • absence of contraindication to 2% chlorhexidine in alcohol or yellow-orange S (E110)

Exclusion Criteria:

  • Change case of cardiac resynchronization
  • Pregnant or breast-feeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01841242

Contact: Aline SCHMID, CRA (0)477828679 ext +33
Contact: Kaissa DANOUN, CRA (0)477829251 ext +33

CH d'Aix en Provence Recruiting
Aix En Provence, France, 13100
Principal Investigator: Jerome TAIEB, MD         
CHU d'Amiens Recruiting
Amiens, France, 80000
Principal Investigator: Jean-Sylvain HERMIDA, MD PhD         
Sub-Investigator: Serge QUENUM, MD         
Sub-Investigator: Maciej KUBALA, MD         
CHU d'Angers Recruiting
Angers, France, 49000
Principal Investigator: Jean-Marc DUPUIS, MD PhD         
Sub-Investigator: Sophie LE PAGE, MD         
Sub-Investigator: Marjorie NIRO, MD         
CH d'Annecy Recruiting
Annecy, France, 74000
Principal Investigator: Antoine DOMPNIER, MD         
CHU de Bordeaux Recruiting
Bordeaux, France, 33000
Principal Investigator: Pierre BORDACHAR, MD PhD         
Sub-Investigator: Philippe RITTER, MD         
Sub-Investigator: Sunthareth YEIM, MD         
Sub-Investigator: Adlane ZEMMOURA, MD         
Sub-Investigator: Sana AMRAOUI, MD         
Sub-Investigator: Sylvain PLOUX, MD         
Sub-Investigator: Nicolas KLOTZ, MD         
CHU de Brest Recruiting
Brest, France, 29000
Principal Investigator: Jacques MANSOURATI, MD PhD         
Sub-Investigator: Jérome ABALEA, MD         
CHU de Caen Recruiting
Caen, France, 14000
Principal Investigator: Paul MILLIEZ, MD PhD         
Sub-Investigator: Damien LEGALLOIS, MD         
Sub-Investigator: Alain LEBON, MD         
CH de Chartres Not yet recruiting
Chartres, France, 28000
Principal Investigator: Sandrine BAYLE, MD         
Sub-Investigator: Grégoire RANGE, MD         
Sub-Investigator: Hervé GORKA, MD         
CHU de Clermont-Ferrand Recruiting
Clermont-ferrand, France, 63000
Principal Investigator: Yannick SALUDAS, MD PhD         
Sub-Investigator: Frédéric JEAN, MD         
Sub-Investigator: Antoine ROUX, MD         
Sub-Investigator: Romain ESCHALIER, MD         
CHU de Dijon Recruiting
Dijon, France, 21000
Principal Investigator: Gabriel LAURENT, MD PhD         
Sub-Investigator: Géraldine BERTAUX CATTAROSSI, MD         
Sub-Investigator: Fabien GARNIER, MD         
CHU de Grenoble Recruiting
Grenoble, France, 38000
Principal Investigator: Pascal DEFAYE, MD PhD         
Sub-Investigator: Peggy JACON, MD         
Sub-Investigator: Alix MARTIN, MD         
CH la Rochelle Recruiting
La Rochelle, France, 17000
Principal Investigator: Paul BRU, MD         
Sub-Investigator: Antoine MILHEM, MD         
Sub-Investigator: Cécile DUPLANTIER DUCHENE, MD         
CHU de Lille Suspended
Lille, France, 59000
Ch St Joseph St Luc Recruiting
Lyon, France, 69000
Principal Investigator: Benjamin GAL, MD         
Sub-Investigator: Michel LOPEZ, MD         
Sub-Investigator: Julien PINEAU, MD         
AP-HM Recruiting
Marseille, France, 13000
Principal Investigator: Jean-Claude DEHARO, MD PhD         
Sub-Investigator: Sébastien PREVOT, MD         
Sub-Investigator: Alexis MECHULAN, MD         
Sub-Investigator: Frederic FRANCESCHI, MD         
CHU de Montpellier Terminated
Montpellier, France, 34000
CHU de Nimes Suspended
Nimes, France, 30000
CH de Périgueux Recruiting
Perigueux, France, 24000
Principal Investigator: Jean LITALIEN, MD         
CHU de Reims Recruiting
Reims, France, 51000
Sub-Investigator: Jean-Pierre CHABERT, MD PhD         
Principal Investigator: Francois LESAFFRE, MD         
CHU de Rouen Recruiting
Rouen, France, 76000
Principal Investigator: Frédéric ANSELME, MD PhD         
Sub-Investigator: Arnaud SAVOURE, MD         
Sub-Investigator: Kévin GARDEY, MD         
CHU de Saint-Etienne Recruiting
Saint-etienne, France, 42000
Principal Investigator: Antoine DA COSTA, MD PhD         
Sub-Investigator: Cécile ROMEYER BOUCHARD, MD         
Sub-Investigator: Laurence BISCH, MD         
Sub-Investigator: Alexie GATE MARTINET, MD         
CHU de Strasbourg Recruiting
Strasbourg, France, 67000
Principal Investigator: Babe BAKOUBOULA, MD PhD         
CHU de Toulouse Recruiting
Toulouse, France, 31000
Principal Investigator: Alexandre DUPARC, MD PhD         
Sub-Investigator: Pierre MONDOLY, MD         
Sub-Investigator: Marc DELAY, MD         
Sub-Investigator: Anne ROLLIN, MD         
Sub-Investigator: Emilie THOMSON, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Principal Investigator: Antoine DA COSTA, MD PhD CHU de Saint-Etienne

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne Identifier: NCT01841242     History of Changes
Other Study ID Numbers: 1108096
2012-000803-33 ( EudraCT Number )
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Cardiac Resynchronization Device
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Chlorhexidine gluconate
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents
Trace Elements
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes