Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection in Patients After Cesarean Section. Randomized, Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Surgical Site infection (SSI)
研究概览
简要总结
Many solutions are used for cleaning the skin of a patient previous to a surgery. Although the efficacy of clorhexidine has been proved in other surgical procedures, there is only a retrospective study in cesarean section (they report no benefit of one solution over the other). The investigators would like to evaluate the difference in surgical site infection in patients after cesarean section comparing preparation of the skin with clorhexidine versus povidone.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age > 32 weeks
- •Emergency cesarean section
排除标准
- •Allergy to clorhexidine
- •Allergy to povidone
- •Evidence of infection in the surgical site
- •Loss to follow up at 15 days
- •Surgeries that due to the emergency of the case do not allow the five minutes of skin cleaning.
研究组 & 干预措施
Clorhexidine
Skin prior to the surgical incision will be cleaned for five minutes with Clorhexidine.
干预措施: Clorhexidine (Procedure)
结局指标
主要结局
Surgical Site infection (SSI)
时间窗: 3 days
The patients will be evaluated for evidence of surgical site infection before leaving the hospital, three (3) days after surgery. The presence of fever, suppurative secretion through the wound or cutaneous changes compatible witn infection will be considered a surgical site infection (SSI). This outcome will be evaluated with a qualitative variable (presence of SSI). The patients will be classified in accordance as "With SSI" or "Without SSI".
次要结局
- Hospitalization(15 days)
研究者
Osvaldo A. Reyes T.
Coordinator of Research
Saint Thomas Hospital, Panama