Efficacy of Home Pre-Operative Use of 2% Chlorhexidine Cloths Prior to Shoulder Surgery
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
- Number of Patients With a Clinically Diagnosed Infection
研究概览
简要总结
We intend to determine how effective the use of a 2% Chlorhexidine Cloth is in terms of eliminating the bacterial load on patients undergoing shoulder surgery. We will be comparing the Chlorhexidine Cloths with a control group which will be performing an ordinary shower prior to surgery. At this time, it is standard of care to only take an ordinary shower the evening prior, and the morning of surgery.
详细描述
The use of home preoperative chlorhexidine wash has been used in various surgical fields for the prevention of perioperative infections. However, it's use in shoulder surgery has not been published up to this point. The shoulder has a unique microbial flora due to the prevalence of Propionibacterium acnes, a bacteria implicated in surgical site infections after shoulder surgery. This study is designed to examine the efficacy of using a preoperative Sage 2% chlorhexidine cloth in reducing bacterial load in the pre-operative area as well as in reducing post-operative surgical site infections after shoulder surgery. This study will compare the rate of post-operative infections and also the rate of positive skin cultures. The skin cultures will be obtained in the preoperative area from subjects who used the Sage 2% Chlorhexidine cloth protocol pre-operatively (n=50) versus those who used only soap and water (n=50).
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
- Double (Investigator, Outcomes Assessor)
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
- •Patient undergoing shoulder surgery (open or arthroscopic)
排除标准
- •Patient unwilling to comply with instructions
- •Active infection in the operative extremity
- •Documented allergic reaction to chlorhexidine
研究组 & 干预措施
2% Chlorhexidine cloth
This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
干预措施: 2% Chlorhexidine cloth (Drug)
结局指标
主要结局
Number of Patients With a Clinically Diagnosed Infection
时间窗: 2 months post-operatively
次要结局
- Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery(7 days)
研究者
Gordon Nuber
Professor of Orthopaedics
Northwestern University