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

• Status: Completed
• Trial end date: 2021-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: CareFusion; Ministry of Health, France
• Treatments: Cadexomer iodine; Chlorhexidine; Chlorhexidine gluconate; Iodine; Povidone; Povidone-Iodine

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