Efficacy of Surgical Preparation Solutions in Knee Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Quantitative and qualitative bacterial load
研究概览
简要总结
The goal of this study is to determine the superiority of surgical scrub preparations in total knee arthroplasty based on the bacterial counts present on the skin surface and in the deep joint tissues. These counts will be obtained by culturing the skin prior to any scrub preparation, post preparation after the application of the sterile drapes, deep joint tissue sample prior to wound closure, and immediately post wound closure. This study will provide an assessment of the management of sterility by comparing quantitative and qualitative cultures immediately after surgical scrub preparation and the maintenance of sterility throughout the procedure. This study will enhance prior research efforts by contributing quantitative bacterial load and bacterial load within the surgical wound at closure.
详细描述
Prospective randomized study of commonly used surgical prep solutions comparing superiority of Chloraprep to Duraprep
- Primary Outcome Measure: Quantitative and qualitative bacterial load pre-surgical preparation, post-surgical preparation, and post-wound closure to be obtained by skin cultures and one deep joint tissue culture from the joint space prior to wound closure.
- Secondary Outcome Measure: Rates of surgical site infection in ChloraPrep and DuraPrep groups to be outlined below.
Patient Population:
Subjects will be recruited from Dr. Brindley's and Dr. Jenkins clinic which are selected for primary total knee arthroplasty.
Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>18 years old and less than 89
- •Undergoing primary total knee arthroplasty
- •Not undergoing surgical intervention for infection
排除标准
- •Injury due to trauma
- •Open wound at the incision site determined by pre-op history and physical
- •Abrasion in the vicinity of the planned incision site determined by pre-op history and physical
- •Active infection at or near the surgical incision site determined by pre-op history and physical
- •Active infection somewhere else in the body determined by pre-op labs and history and physical
- •Prior history of surgical infection or bacteremia determined by pre-op history and physical
- •History of rheumatoid arthritis determined by pre-op history and physical
- •History of autoimmune disorder determined by pre-op history and physical
- •Immunosuppressed patient determined by pre-op history and physical
- •Known allergy to iodine, isopropyl alcohol or Chlorhexidine
结局指标
主要结局
Quantitative and qualitative bacterial load
时间窗: At time of surgery
Quantitative and qualitative bacterial load will be obtained by skin cultures and one deep joint tissue culture from the joint space prior to wound closure in primary and revision total knee surgeries.
次要结局
- Rate of surgical site infections(at time of surgery)