Prospective Study of Chloridehexidine/Alcohol Versus Jodine/Povidine in Forefoot Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- number of positive swab cultures
研究概览
简要总结
The study will prospectively compare the efficacy and safety of chloride hexidine soluted in alcohol with povidine-jodine soluted in alcohol in forefoot surgery.
详细描述
It will be a comparative study in which we will swab cultures before skin preparation directly after skin preparation and at the and of the operation (hallux valgus correction and arthrodesis of the first metatarsophalangeal joint.
There will be a quantitative and quality analysis of the swabs. We will also measure allergic reactions. During the post-operative period of 6 weeks we will measure the wound infections stated by Prezies.
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
- None
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
- •age above 18 years
- •written informed consent
- •indication for hallux valgus correction or arthrodesis of the first metatarsophalageal joint
排除标准
- •allergic for jodine-povidine and/or chloride-hexidine
- •active infection
- •skin defect
- •blood clotting or coagulation disorder
研究组 & 干预措施
chloride-hexidine soluted in alcohol
patients will have skin preparation with chloride-hexidine soluted in alcohol prior to their forefoot surgery.
Skin swabs will be taken prior to skin preparation, after skin preparation and after skin closure at the end of the operation
干预措施: skin preparation (Procedure)
povidine-jodine soluted in alcohol
skin perparation will be done with povidine-jodine soluted in alcohol prior to forefoot surgery.
干预措施: skin preparation (Procedure)
结局指标
主要结局
number of positive swab cultures
时间窗: From start surgery week until 48 hours post-operatively
During surgery swabs will be taken before skin desinfection, after skin desinfection and at the end of the surgery. We will count the number of positive swab cultures taken from the webspace of their first and second toe and at the place of incision 48 hours post-operatively.
wound infection
时间窗: until 6 weeks postoperatively
we will count the number of wound infections, stated by Prezies, for a period of 6 weeks postoperatively
次要结局
- Allergic events(Until 6 weeks postoperatively)