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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
Collaborators:
Ministry of Health, France
CareFusion
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01841242
First received: April 24, 2013
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Heart Failure
Arrhythmia
Drug: alcoholic povidone iodine
Drug: alcoholic chlorhexidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Infection [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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:
  • Cardiovascular event [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Major cardiovascular events such as heart failure, embolic right heart.

  • Side Effects [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Side effects attributable to local treatment.


Estimated Enrollment: 2276
Study Start Date: April 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01841242

Contacts
Contact: Antoine DA COSTA, MD PhD (0)477828679 ext +33 dakosta@orange.fr
Contact: Marion PASQUALINI, CRA (0)477829251 ext +33 pasqualini.marion@chu-st-etienne.fr

Locations
France
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         
CHU de Bordeaux Recruiting
Bordeaux, France, 33000
Principal Investigator: Pierre BORDACHAR, MD PhD         
CHU de Brest Recruiting
Brest, France, 29000
Principal Investigator: Jacques MANSOURATI, MD PhD         
CHU de Caen Recruiting
Caen, France, 14000
Principal Investigator: Paul MILLIEZ, MD PhD         
CHU de Clermont-Ferrand Recruiting
Clermont-ferrand, France, 63000
Principal Investigator: Yannick SALUDAS, MD PhD         
CHU de Dijon Recruiting
Dijon, France, 21000
Principal Investigator: Gabriel LAURENT, MD PhD         
CHU de Grenoble Recruiting
Grenoble, France, 38000
Principal Investigator: Pascal DEFAYE, MD PhD         
CH la Rochelle Recruiting
La Rochelle, France, 17000
Principal Investigator: Paul BRU, MD         
CHU de Lille Not yet recruiting
Lille, France, 59000
Principal Investigator: Didier KLUG, MD PhD         
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         
CHU de Montpellier Recruiting
Montpellier, France, 34000
Principal Investigator: Jean-Luc PASQUIER, MD PhD         
CHU de Nimes Not yet recruiting
Nimes, France, 30000
Principal Investigator: Lionel BECK, MD PhD         
CHU de Reims Recruiting
Reims, France, 51000
Principal Investigator: Jean-Pierre CHABERT, MD PhD         
Sub-Investigator: Francois LESAFFRE, MD         
CHU de Rouen Recruiting
Rouen, France, 76000
Principal Investigator: Frédéric ANSELME, MD PhD         
CHU de Saint-Etienne Recruiting
Saint-etienne, France, 42000
Principal Investigator: Antoine DA COSTA, MD PhD         
Sub-Investigator: Cécile ROMEYER BOUCHARD, 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         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
CareFusion
Investigators
Principal Investigator: Antoine DA COSTA, MD PhD CHU de Saint-Etienne
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01841242     History of Changes
Other Study ID Numbers: 1108096, 2012-000803-33
Study First Received: April 24, 2013
Last Updated: March 28, 2014
Health Authority: France: French Data Protection Authority
France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Failure
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Povidone
Chlorhexidine
Chlorhexidine gluconate
Iodine
Cadexomer iodine
Povidone-Iodine
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014