Randomized,Prospective Evaluation of 2% Chlorhexidine Gluconate Cloths to Reduce Surgical Site Infections in Cardiothoracic Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 739
- 试验地点
- 5
- 主要终点
- Surgical site infections
研究概览
简要总结
The purpose of the study is to see if using 2% Chlorhexidine cloths will reduce surgical site infections in patients having elective cardiac surgery.
详细描述
A randomized, prospective study utilizing 2% Chlorhexidine cloths to evaluate the product's effectiveness in reducing surgical site infections in elective cardiothoracic surgery patients. Sage 2% chlorhexidine cloths are approved by the Food and Drug Administration (FDA) for preparation of skin prior to surgery.
The study hypothesis is that the preoperative surgical preparation with 2% chlorhexidine cloths, which leaves chlorhexidine on the skin, will reduce surgical site infections by 50% as compared to current standard procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective cardiothoracic surgery patients > 18 years old.
- •Informed consent obtained
排除标准
- •Any current known allergies to chlorhexidine gluconate
- •Currently taking any oral or topical antibiotics
- •Any active skin rashes or breaks in the skin on areas to be treated with chlorhexidine gluconate
- •A current active skin disease or inflammatory skin condition, known pre-existing skin infection, including contact dermatitis that is currently being treated with an antibiotic
- •Any medical condition or use of any medications that in the opinion of the Principal Investigator preclude participation.
- •Unwillingness or failure to fulfill requirements of the study
结局指标
主要结局
Surgical site infections
时间窗: Through 90 days post procedure
Subjects will be assessed at 30 days and 90 days post operatively for any surgical site infection
次要结局
未报告次要终点
研究者
Michael Ackerman
Principal Investigator
University of Rochester