Prevalence of Cutaneous Enterococci at Femoral Insertion Site in Transcatheter Aortic Valve Implantation (TAVI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Enterococci prevalence
研究概览
简要总结
The general rules of antibiotic prophylaxis in surgery or interventional medicine include the choice of an antibiotic active on the bacteria most frequently encountered in surgical site infections. This antibiotic must cover, the bacteria present on the skin and recognized as responsible for surgical site infections.
The aim of this study is to identify bacteria found in skin flora in the inguinal region of patients undergoing Transcatheter Aortic Valve Implantation (TAVI). Flora found will allow to evaluate the impact of skin preparation and antibiotic prophylaxis protocols as they are currently practiced.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled for aortic valve replacement by TAVI procedure with trans femoral approach
- •Patient with pre-TAVI assessment performed at Clinique Pasteur
- •Patient affiliated or beneficiary of a social security scheme
- •Patient accepting to participate and having given his no objection
排除标准
- •TAVI procedure by non-trans femoral approach
- •Protected patients: Adults under guardianship or other legal protection; Pregnant or breastfeeding woman; Hospitalized without consent.
结局指标
主要结局
Enterococci prevalence
时间窗: At Day 0 at TAVI intervention time (preoperative)
Proportion of patients with Enterococcus feacalis and other Enterococci in inguinal flora before TAVI
次要结局
- Skin flora of the groin(At Day 0 at TAVI intervention time (preoperative) after skin disinfection)
- Infectious events(From day of TAVI to 1 year after intervention)
- Skin flora of the groin(At Day 0 at TAVI intervention time (preoperative) before skin disinfection)
研究者
Dr Benoit Fontenel
Principal investigator, MD
Clinique Pasteur