Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,874
- 试验地点
- 1
- 主要终点
- Surgical Site Infections Occurring Within 12 Months of Surgical Procedure
研究概览
简要总结
We hypothesize the application of mupirocin or povidone-iodine to the nares is equally effective in short term Staphylococcus aureus(SA)suppression. Our overall study objective is to measure the rate of deep and superficial Surgical Site Infections (SSIs) after primary hip, knee, shoulder and elbow arthroplasty surgery and primary spinal fusion surgery requiring implantation of prosthetic material, when the patient receives either nasal mupirocin or nasal povidone-iodine prior to surgery.
Secondary study objectives include:
- Measure hospital length of stay and re-admission rates in the mupirocin and povidone-iodine groups.
- Measure adverse events related to mupirocin and povidone-iodine.
- Measure rate of SA resistance to mupirocin.
详细描述
We hypothesize the application of mupirocin or povidone-iodine to the nares is equally effective in short term Staphylococcus aureus(SA)suppression. Our overall study objective is to measure the rate of deep and superficial Surgical Site Infections (SSIs) after primary hip, knee, shoulder and elbow arthroplasty surgery and primary spinal fusion surgery requiring implantation of prosthetic material, when the patient receives either nasal mupirocin or nasal povidone-iodine prior to surgery.
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
- Single (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
- 否
入选标准
- •Primary arthroplasty or spinal fusion surgery
- •Age greater than 18 years
排除标准
- •Revision arthroplasty
- •Revision spinal fusion surgery
- •Primary spine surgery without implantation of prosthetic material
- •Allergy to mupirocin
- •Allergy to povidone-iodine
- •Pregnancy
- •Breastfeeding
研究组 & 干预措施
3M Skin and Nasal Antiseptic
Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation
干预措施: 3M Skin and Nasal Antiseptic (Drug)
Bactroban Nasal
Mupirocin calcium ointment, 2%
干预措施: mupirocin calcium ointment, 2% (Drug)
结局指标
主要结局
Surgical Site Infections Occurring Within 12 Months of Surgical Procedure
时间窗: 12 months
Measure the rate (number and percent of patients) with deep and superficial surgical site infections after primary orthopedic surgery and primary spinal fusion surgery requiring implantation of prosthetic material.
次要结局
- Measure Rate of Staphylococcus Aureus Resistance to Mupirocin.(Isolates collected and frozen immediately post-surgery.)
- Re-admission Rates in the Mupirocin and Povidone-iodine Groups.(12 months)
- Measure Hospital Length of Stay in the Mupirocin and Povidone-iodine Groups.(Post-surgery)