Comparison of Chlorhexidine Gluconate and Povidone Iodine as a Preoperative Antisepsis in Clean-contaminated Abdominal Surgery : a Randomized Prospective Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 534
- 试验地点
- 1
- 主要终点
- Number of patients with Surgical Site infection within 1month
研究概览
简要总结
The purpose of this study is to determine which drug (chlorhexidine gluconate vs. povidone iodine) as a preoperative antisepsis in clean-contaminated abdominal surgery (liver, hepatobiliary, small or large bowel, stomach) is effective.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resection of following organs (clean-contaminated open surgery)
- •Liver, Pancreas, Bile duct, Duodenum
- •Colon, Small bowel
- •Aged 20 - 85 years old
- •Use Prophylactic antibiotics
- •Use Preoperative bowel preparation
- •Elective operation
- •ASA classification 1-2 ASA I : no known systemic disease ASA II : single systemic disease & mild or well controlled ASA III : multiple systemic diseases or moderately controlled systemic disease ASA IV : poorly controlled systemic diseases
- •adequate organ functions defined as indicated below:
- •WBC 3000 ~ 12 000/mm3
- •> Hb 8.0 g/dl
- •> Plt 100 000/mm3
- •< Cr 1.2 mg/dl
排除标准
- •allergy to chlorhexidine or povidone
- •clean surgery or contaminated surgery
- •patients who cannot be followed up during 1 month
- •patients taking immunosuppressant drugs or chemotherapy agents
- •emergent surgery and reoperation
- •uncontrolled diabetes, BMI > 30 kg/m2
- •vulnerable patients
研究组 & 干预措施
Povidone Iodine
7.5% povidone iodine soaping 10% povidone iodine painting
干预措施: Povidone-Iodine (Drug)
Chlorhexidine Gluconate
4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting
干预措施: Chlorhexidine gluconate (Drug)
结局指标
主要结局
Number of patients with Surgical Site infection within 1month
时间窗: within 1 month
Check the surgical site infection (SSI) rate within one month Superficial SSI, Deep SSI, Organ Site SSI decided by physician CDC Definition in 1999 Superficial incisional infection : involving only the skin or subcutaneous tissue of the incision Deep incisional Infection : involving the deep tissues (i.e. fascial and muscle layers) Organ Space Infection : involving any part of the anatomy (i.e. organ/space), other than the incision
次要结局
- Identify the infection source(within 1month)
- Number of patients with Drug Side effect.(Within 1 month)
- Number of patients with the postoperative sepsis induced by wound infection(within 1 month)
研究者
Seung Duk Lee
Clinical Fellow, Center for Liver Cancer
National Cancer Center, Korea