Ignite Creation Date:
2024-05-06 @ 1:34 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01841242
Status:
COMPLETED
Last Update Posted:
2021-08-06
First Post:
2013-04-24
Brief Title:
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
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Comparison of Alcoholic Chlorhexidine 2 Versus Alcoholic Povidone Iodine for Infections Prevention With Cardiac Resynchronization Therapy Device Implantation
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHLOVIS
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 24 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 APIin 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 95 161 p 0004 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-000803-33 | EUDRACT_NUMBER | None | None |