Comparison of Alcoholic Chlorhexidine 2% Versus Alcoholic Povidone Iodine for Infections Prevention With Cardiac Resynchronization Therapy Device Implantation (CHLOVIS)
Primary Purpose
Heart Failure, Arrhythmia
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
alcoholic povidone iodine
alcoholic chlorhexidine
Sponsored by

About this trial
This is an interventional prevention trial for Heart Failure focused on measuring Infection, Cardiac Resynchronization Device, Heart Failure
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
Sites / Locations
- CH d'Aix en Provence
- CHU d'Amiens
- CHU d'Angers
- CH d'Annecy
- CH d'Avignon
- CHU de Bordeaux
- CHU de Brest
- CHU de Caen
- CH de Chartres
- CHU de Clermont-Ferrand
- CHU de Dijon
- CHU de Grenoble
- CH la Rochelle
- CHU de Lille
- Ch St Joseph St Luc
- AP-HM
- CHU de Montpellier
- CHU de Nimes
- CH de Périgueux
- CHU de Reims
- CHU de Rouen
- CHU de Saint-Etienne
- CHU de Strasbourg
- CHU de Toulouse
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
alcoholic povidone iodine
alcoholic chlorhexidine
Arm Description
Betadine Alcoolique 5% One cutaneous application before implant procedure
ChloraPrep 2% One cutaneous application before implant procedure
Outcomes
Primary Outcome Measures
Infection
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
Major cardiovascular events such as heart failure, embolic right heart.
Side Effects
Side effects attributable to local treatment.
Full Information
NCT ID
NCT01841242
First Posted
April 24, 2013
Last Updated
August 5, 2021
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France, CareFusion
1. Study Identification
Unique Protocol Identification Number
NCT01841242
Brief Title
Comparison of Alcoholic Chlorhexidine 2% Versus Alcoholic Povidone Iodine for Infections Prevention With Cardiac Resynchronization Therapy Device Implantation
Acronym
CHLOVIS
Official Title
Comparison of Alcoholic Chlorhexidine 2% Versus Alcoholic Povidone Iodine for Infections Prevention With Cardiac Resynchronization Therapy Device Implantation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 23, 2013 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France, CareFusion
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Arrhythmia
Keywords
Infection, Cardiac Resynchronization Device, Heart Failure
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
2 randomized groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2276 (Actual)
8. Arms, Groups, and Interventions
Arm Title
alcoholic povidone iodine
Arm Type
Active Comparator
Arm Description
Betadine Alcoolique 5% One cutaneous application before implant procedure
Arm Title
alcoholic chlorhexidine
Arm Type
Experimental
Arm Description
ChloraPrep 2% One cutaneous application before implant procedure
Intervention Type
Drug
Intervention Name(s)
alcoholic povidone iodine
Other Intervention Name(s)
Betadine alcoolique 5%
Intervention Type
Drug
Intervention Name(s)
alcoholic chlorhexidine
Other Intervention Name(s)
ChloraPrep 2%
Primary Outcome Measure Information:
Title
Infection
Description
Local or general infection in relation to the implantable device (skin erosion, externalization, local flow, local abscess, sepsis with or without bacteremia)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Cardiovascular event
Description
Major cardiovascular events such as heart failure, embolic right heart.
Time Frame
24 months
Title
Side Effects
Description
Side effects attributable to local treatment.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine DA COSTA, MD PhD
Organizational Affiliation
CHU de Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH d'Aix en Provence
City
Aix En Provence
ZIP/Postal Code
13100
Country
France
Facility Name
CHU d'Amiens
City
Amiens
ZIP/Postal Code
80000
Country
France
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
CH d'Annecy
City
Annecy
ZIP/Postal Code
74000
Country
France
Facility Name
CH d'Avignon
City
Avignon
Country
France
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
CHU de Brest
City
Brest
ZIP/Postal Code
29000
Country
France
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CH de Chartres
City
Chartres
ZIP/Postal Code
28000
Country
France
Facility Name
CHU de Clermont-Ferrand
City
Clermont-ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
CH la Rochelle
City
La Rochelle
ZIP/Postal Code
17000
Country
France
Facility Name
CHU de Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Ch St Joseph St Luc
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
AP-HM
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
CHU de Nimes
City
Nimes
ZIP/Postal Code
30000
Country
France
Facility Name
CH de Périgueux
City
Perigueux
ZIP/Postal Code
24000
Country
France
Facility Name
CHU de Reims
City
Reims
ZIP/Postal Code
51000
Country
France
Facility Name
CHU de Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
CHU de Saint-Etienne
City
Saint-etienne
ZIP/Postal Code
42000
Country
France
Facility Name
CHU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Alcoholic Chlorhexidine 2% Versus Alcoholic Povidone Iodine for Infections Prevention With Cardiac Resynchronization Therapy Device Implantation
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