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

NCT ID: NCT01841242

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-23
• Study Completion Date: 2021-01-31

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.

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.

Conditions

Heart Failure; Arrhythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

alcoholic povidone iodine

Betadine Alcoolique 5% One cutaneous application before implant procedure

Group Type: ACTIVE_COMPARATOR

alcoholic povidone iodine

Intervention Type: DRUG

alcoholic chlorhexidine

ChloraPrep 2% One cutaneous application before implant procedure

Group Type: EXPERIMENTAL

alcoholic chlorhexidine

Intervention Type: DRUG

Interventions

alcoholic povidone iodine

Intervention Type: DRUG

alcoholic chlorhexidine

Intervention Type: DRUG

Other Intervention Names

Betadine alcoolique 5%; ChloraPrep 2%

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

CareFusion

INDUSTRY

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoine DA COSTA, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

CH d'Aix en Provence

Aix-en-Provence, , France

CHU d'Amiens

Amiens, , France

CHU d'Angers

Angers, , France

CH d'Annecy

Annecy, , France

CH d'Avignon

Avignon, , France

CHU de Bordeaux

Bordeaux, , France

CHU de Brest

Brest, , France

CHU de Caen

Caen, , France

CH de Chartres

Chartres, , France

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

CHU de Dijon

Dijon, , France

CHU de Grenoble

Grenoble, , France

CH la Rochelle

La Rochelle, , France

CHU de Lille

Lille, , France

Ch St Joseph St Luc

Lyon, , France

AP-HM

Marseille, , France

CHU de Montpellier

Montpellier, , France

CHU de Nimes

Nîmes, , France

CH de Périgueux

Périgueux, , France

CHU de Reims

Reims, , France

CHU de Rouen

Rouen, , France

CHU de Saint-Etienne

Saint-Etienne, , France

CHU de Strasbourg

Strasbourg, , France

CHU de Toulouse

Toulouse, , France

Countries

France

Other Identifiers

2012-000803-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1108096

Identifier Type: -

Identifier Source: org_study_id