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

Heart Failure Clinical Trial

— CHLOVIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841242
• Other study ID #: 1108096
• Secondary ID: 2012-000803-33
• Status: Completed
• Phase: Phase 4
• Start date: April 23, 2013
• Est. completion date: January 31, 2021

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2276
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia
• Heart Failure
• Infection

Intervention

Drug:
• alcoholic povidone iodine

• alcoholic chlorhexidine

Locations

Country	Name	City	State
France	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	Nimes
France	CH de Périgueux	Perigueux
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

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	CareFusion, Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cardiovascular event	Major cardiovascular events such as heart failure, embolic right heart.	24 months
Secondary	Side Effects	Side effects attributable to local treatment.	24 months