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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT01841242

Collaborator

Ministry of Health, France (Other), CareFusion (Industry)

2,276

Enrollment

Locations

Arms

93.3

Actual Duration (Months)

94.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2276 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2 randomized groups2 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 :

Apr 23, 2013

Actual Primary Completion Date :

Jan 31, 2021

Actual Study Completion Date :

Jan 31, 2021

Arms and Interventions

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%

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%

Outcome Measures

Primary Outcome Measures

Infection [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

Cardiovascular event [24 months]
Major cardiovascular events such as heart failure, embolic right heart.
Side Effects [24 months]
Side effects attributable to local treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	CH d'Aix en Provence	Aix En Provence	France	13100
2	CHU d'Amiens	Amiens	France	80000
3	CHU d'Angers	Angers	France	49000
4	CH d'Annecy	Annecy	France	74000
5	CH d'Avignon	Avignon	France
6	CHU de Bordeaux	Bordeaux	France	33000
7	CHU de Brest	Brest	France	29000
8	CHU de Caen	Caen	France	14000
9	CH de Chartres	Chartres	France	28000
10	CHU de Clermont-Ferrand	Clermont-ferrand	France	63000
11	CHU de Dijon	Dijon	France	21000
12	CHU de Grenoble	Grenoble	France	38000
13	CH la Rochelle	La Rochelle	France	17000
14	CHU de Lille	Lille	France	59000
15	Ch St Joseph St Luc	Lyon	France	69000
16	AP-HM	Marseille	France	13000
17	CHU de Montpellier	Montpellier	France	34000
18	CHU de Nimes	Nimes	France	30000
19	CH de Périgueux	Perigueux	France	24000
20	CHU de Reims	Reims	France	51000
21	CHU de Rouen	Rouen	France	76000
22	CHU de Saint-Etienne	Saint-etienne	France	42000
23	CHU de Strasbourg	Strasbourg	France	67000
24	CHU de Toulouse	Toulouse	France	31000