Povidone Iodine 10% Versus 7.5% Hand Scrub and Cesarean Section Wound Infections: A Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,231
- 试验地点
- 1
- 主要终点
- The difference of incidence of surgical site infection between both groups
研究概览
简要总结
The aim of this randomized clinical trial is to compare the efficiency of hand scrubbing by Povidone-Iodine solution 10% over 7.5% concentration in decreasing post-cesarean section wound infections & compare side effects of both agents.
详细描述
For centuries, hand washing with soap and water has been considered the main approach for personal hygiene. In the community, hand hygiene has been known to prevent infectious diseases and to decrease the burden of disease. Currently, hand hygiene is considered the most important measure for preventing the spread of pathogens in health-care settings.
There are multiple agents used for surgical hand scrubbing as alcohol, chlorhexidine, iodine/iodophors, para-chloro-meta-xylenol & triclosan. Ideally, the optimum antiseptic used for scrub should have broad spectrum of activity, persistent effect & fast acting. Unfortunately most studies evaluating surgical scrub antiseptics have focused on measuring hand bacterial colony counts. No randomized clinical trials have evaluated the impact of surgical scrub choice on surgical site infection risk & proven its efficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •elective caesarian section (CS)
排除标准
- •diabetes,
- •immuno-compromised patients
研究组 & 干预措施
Povidone Iodine 10%
Using Povidone Iodine 10% hand scrub before caesarian section
干预措施: Povidone Iodine 10% vand cesarean section wound infections (Drug)
Povidone Iodine 7.5% hand scrub
Using Povidone Iodine 7.5% hand scrub before caesarian section
干预措施: Povidone Iodine 7.5% vand cesarean section wound infections (Drug)
结局指标
主要结局
The difference of incidence of surgical site infection between both groups
时间窗: 4 month
Determine the difference in incidence of surgical site infection between Povidone Iodine 10% versus 7.5% hand scrub
次要结局
- The difference in the side effects between both groups e.g. dermatitis(4 month)
研究者
Mohammed Khairy Ali
Principal Investigator
Assiut University