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

This study is currently recruiting participants.
Verified March 2014 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
Collaborators:
Ministry of Health, France
CareFusion
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01841242
First received: April 24, 2013
Last updated: March 28, 2014
Last verified: March 2014

April 24, 2013
March 28, 2014
April 2013
December 2017   (final data collection date for primary outcome measure)
Infection [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Local or general infection in relation to the implantable device (skin erosion, externalization, local flow, local abscess, sepsis with or without bacteremia)
Same as current
Complete list of historical versions of study NCT01841242 on ClinicalTrials.gov Archive Site
  • Cardiovascular event [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Major cardiovascular events such as heart failure, embolic right heart.
  • Side Effects [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Side effects attributable to local treatment.
Same as current
Not Provided
Not Provided
 
Comparison of Alcoholic Chlorhexidine 2% Versus Alcoholic Povidone Iodine for Infections Prevention With Cardiac Resynchronization Therapy Device Implantation
Comparison of Alcoholic Chlorhexidine 2% Versus Alcoholic Povidone Iodine for Infections Prevention With Cardiac Resynchronization Therapy Device Implantation

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Heart Failure
  • Arrhythmia
  • Drug: alcoholic povidone iodine
    Other Name: Betadine alcoolique 5%
  • Drug: alcoholic chlorhexidine
    Other Name: ChloraPrep 2%
  • Active Comparator: alcoholic povidone iodine
    Betadine Alcoolique 5% One cutaneous application before implant procedure
    Intervention: Drug: alcoholic povidone iodine
  • Experimental: alcoholic chlorhexidine
    ChloraPrep 2% One cutaneous application before implant procedure
    Intervention: Drug: alcoholic chlorhexidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2276
December 2017
December 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Antoine DA COSTA, MD PhD (0)477828679 ext +33 dakosta@orange.fr
Contact: Marion PASQUALINI, CRA (0)477829251 ext +33 pasqualini.marion@chu-st-etienne.fr
France
 
NCT01841242
1108096, 2012-000803-33
No
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
  • Ministry of Health, France
  • CareFusion
Principal Investigator: Antoine DA COSTA, MD PhD CHU de Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP