Comparative Study of Two Antiseptics Solutions for the Prevention of Surgical Site Infection
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 432
- 试验地点
- 1
- 主要终点
- Surgical site infection rates
研究概览
简要总结
The purpose of this study is to determine whether hypochlorous acid is an effective antiseptic agent to prevent surgical site infection.
详细描述
A topical antimicrobial that decrease the bacterial bioburden of surgical wounds without impairing the wound's ability to heal is a need. A stabilized form of hypochlorous acid has been demonstrated in vitro and in animal studies to possess properties that could fulfill these criteria but it is imperative to assess its efficacy and safety in humans.
To assess hypochlorous acid efficacy and safety, it was designed a clinical controlled randomized trial to compare hypochlorous acid to iodopovidone, the gold standard, in preoperative scrub of surgical area.
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
- Triple (Participant, 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
- 否
入选标准
- •All patients over 18 years old, who are going to be operated
- •Classification of surgical wounds according to the National Research Council as class I or II
- •Risk index classification of the American Society of Anaesthesiology (ASA) as ASA 1 or 2
排除标准
- •Patients requiring mesh or prosthesis or orthesis
研究组 & 干预措施
A
Hypochlorous acid
干预措施: Hypochlorous acid (Drug)
B
Iodopovidone
干预措施: Iodopovidone (Drug)
结局指标
主要结局
Surgical site infection rates
时间窗: until one month (weekly)
次要结局
- Decreasing Colony Forming Unit count (CFU/mL) after using the skin topic antiseptic in surgical site(one week)