Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial (DECO-SSI Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- Overall number of participants with surgical site infections 3 months postoperatively
研究概览
简要总结
Surgical site infections are a major postoperative complication and are mostly due to colonization with endogenous germs, like Staphylococcus aureus, Staphylococcus epidermidis or Propionibacterium acnes. In literature, preoperative decolonization procedures showed a trend in lowering surgical site infection rates, but especially in orthopedic surgery data is controversial and randomized controlled trials are lacking. In the main study, the study investigators aim at performing a controlled prospective randomized interventional trial to measure the impact of preoperative decolonization of nasal Staphylococcus aureus carriers on surgical site infection rates in orthopedic surgery. In an alongside study a controlled prospective randomized interventional trial to measure the impact of preoperative skin decolonization of patients undergoing an orthopedic procedure will be conducted.
详细描述
All participants will be assessed for eligibility during preoperative othopedic consultation. 2-3 weeks prior operation date participants will be screened for Staph. aureus carriage by nose-swab. According to nose-swab results randomizaton and allocation to study arm will be performed.
After one and three months post-operatively participants will be asked by phone interview if surgical site infections occured. Results have to be confirmed by orthopedic surgeon if possible.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient older than 16 years
- •patient undergoing elective orthopedic procedure at the Sonnenhof hospital
- •decolozination protocol can be performed timely
- •signed informed consent
排除标准
- •no orthopedic surgery planned
- •allergy to mupirocin or chlorhexidine
- •presence of a nasal foreign body
- •no informed consent
- •pregnancy
- •decolozination protocol can't be followed timely
- •patients undergoing treatment/surgery for a documented infection
研究组 & 干预措施
Nose-SA-carriers decolonized
Chlorhexidine sol 4%; Mupirocin 2% nasal ointement
1 shower/day for 5 days and Nasal ointement 2x/d in each nostril for 5 days preoperatively
干预措施: Mupirocin 2% nasal ointement (Drug)
Nose-SA-carriers decolonized
Chlorhexidine sol 4%; Mupirocin 2% nasal ointement
1 shower/day for 5 days and Nasal ointement 2x/d in each nostril for 5 days preoperatively
干预措施: Chlorhexidine sol 4% (Drug)
Non-nose-carriers decolonized
Chlorhexidine sol 4% shower, daily for 5 days preoperatively
干预措施: Chlorhexidine sol 4% (Drug)
结局指标
主要结局
Overall number of participants with surgical site infections 3 months postoperatively
时间窗: 3 months
Phone interview and orthopedic assessement
次要结局
- Number of participants with surgical site infections at 1 and 3 months postoperatively(1 and 3 months)