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

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ClinicalTrials.gov Identifier: NCT01841242
Recruitment Status : Active, not recruiting
First Posted : April 26, 2013
Last Update Posted : June 21, 2019
Sponsor:
Collaborators:
Ministry of Health, France
CareFusion
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.

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Study Type : Interventional  (Clinical Trial)
Actual 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 : December 2021
Estimated Study Completion Date : December 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT01841242


Locations
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France
CH d'Aix en Provence
Aix En Provence, France, 13100
CHU d'Amiens
Amiens, France, 80000
CHU d'Angers
Angers, France, 49000
CH d'Annecy
Annecy, France, 74000
CH d'Avignon
Avignon, France
CHU de Bordeaux
Bordeaux, France, 33000
CHU de Brest
Brest, France, 29000
CHU de Caen
Caen, France, 14000
CH de Chartres
Chartres, France, 28000
CHU de Clermont-Ferrand
Clermont-ferrand, France, 63000
CHU de Dijon
Dijon, France, 21000
CHU de Grenoble
Grenoble, France, 38000
CH la Rochelle
La Rochelle, France, 17000
Ch St Joseph St Luc
Lyon, France, 69000
AP-HM
Marseille, France, 13000
CHU de Montpellier
Montpellier, France, 34000
CH de Périgueux
Perigueux, France, 24000
CHU de Reims
Reims, France, 51000
CHU de Rouen
Rouen, France, 76000
CHU de Saint-Etienne
Saint-etienne, France, 42000
CHU de Strasbourg
Strasbourg, France, 67000
CHU de Toulouse
Toulouse, France, 31000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
CareFusion
Investigators
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Principal Investigator: Antoine DA COSTA, MD PhD CHU de Saint-Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov 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: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Infection
Cardiac Resynchronization Device
Heart Failure
Additional relevant MeSH terms:
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Infection
Heart Failure
Heart Diseases
Cardiovascular Diseases
Iodine
Chlorhexidine
Chlorhexidine gluconate
Cadexomer iodine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes