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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Arrhythmia
• Intervention / Treatment: Drug: alcoholic povidone iodine; Drug: alcoholic chlorhexidine

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
• Enrollment (Actual): 2272
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Aix En Provence, France, 13100
    • CH d'Aix en Provence
  • Amiens, France, 80000
    • CHU d'Amiens
  • Angers, France, 49000
    • CHU d'Angers
  • Annecy, France, 74000
    • CH d'Annecy
  • Avignon, France
    • CH d'Avignon
  • Bordeaux, France, 33000
    • CHU de Bordeaux
  • Brest, France, 29000
    • CHU de Brest
  • Caen, France, 14000
    • CHU de Caen
  • Chartres, France, 28000
    • Ch de Chartres
  • Clermont-ferrand, France, 63000
    • CHU de Clermont-Ferrand
  • Dijon, France, 21000
    • CHU de DIJON
  • Grenoble, France, 38000
    • CHU de Grenoble
  • La Rochelle, France, 17000
    • CH La Rochelle
  • Lille, France, 59000
    • CHU de Lille
  • Lyon, France, 69000
    • Ch St Joseph St Luc
  • Marseille, France, 13000
    • AP-HM
  • Montpellier, France, 34000
    • CHU de Montpellier
  • Nimes, France, 30000
    • CHU de Nîmes
  • Perigueux, France, 24000
    • CH de Périgueux
  • Reims, France, 51000
    • CHU de Reims
  • Rouen, France, 76000
    • CHU de ROUEN
  • Saint-etienne, France, 42000
    • Chu de Saint-Etienne
  • Strasbourg, France, 67000
    • CHU de Strasbourg
  • Toulouse, France, 31000
    • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: alcoholic povidone iodine; Betadine Alcoolique 5% One cutaneous application before implant procedure	Drug: alcoholic povidone iodine; Other Names: Betadine alcoolique 5%
Experimental: alcoholic chlorhexidine; ChloraPrep 2% One cutaneous application before implant procedure	Drug: alcoholic chlorhexidine; Other Names: ChloraPrep 2%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection	Local or general infection in relation to the implantable device (skin erosion, externalization, local flow, local abscess, sepsis with or without bacteremia)	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular event	Major cardiovascular events such as heart failure, embolic right heart.	24 months
Side Effects	Side effects attributable to local treatment.	24 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Ministry of Health, France; CareFusion
• Investigators: Principal Investigator: Antoine DA COSTA, MD PhD, Chu de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2013
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: April 24, 2013
• First Submitted That Met QC Criteria: April 25, 2013
• First Posted (Estimated): April 26, 2013

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 30, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Heart Failure; Infection; Cardiac Resynchronization Device
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Infections; Anti-Infective Agents; Anti-Infective Agents, Local; Disinfectants; Plasma Substitutes; Blood Substitutes; Chlorhexidine; Povidone; Povidone-Iodine
• Other Study ID Numbers: 1108096; 2012-000803-33 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO