Supplemental Perioperative Oxygen at 80% FIO2 to Reduce the Incidence of Post-cesarean Wound Infection. A Randomised, Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- Number of participants with surgical site infection (SSI).
研究概览
简要总结
The purpose of this study is to determine if the use of supplemental oxygen at 80% FIO2 can reduce the incidence of surgical site infection after emergency cesarean section.
详细描述
Surgical site infection (SSI) is one of the most important complications that can develop after a cesarean section. SSI can be mild or it can develop into septic shock and death, being cesarean section the most important cause of puerperal infections. Supplemental oxygen at high doses has been advocated as a protective factor for SSI. The purpose of this study is to determine if the use of oxygen at high doses (80% FIO2)can reduce the incidence of SSI after emergency cesarean section.
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 > 37 weeks
- •Emergency cesarean section
- •Regional Anesthesia
排除标准
- •Elective cesarean section
- •Fever of unknown origin at admission
- •Twin pregnancy
- •Chorioamnionitis
- •Acute fetal distress that requires general anesthesia
- •Immunocompromise
- •Maternal Lung/Respiratory Disease
结局指标
主要结局
Number of participants with surgical site infection (SSI).
时间窗: 2 months
The patients will be evaluated for evidence of surgical site infection before leaving the hospital, at 15 and 30 days post surgery. The presence of fever, supurative 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 clasiffied in accordance as "With SSI" or "Without SSI". This will allow us to determine if the use of oxygen at 80% FIO2 can reduce the incidence of SSI.
次要结局
- Number of participants with respiratory complications trans or post surgery.(2 months)
研究者
Osvaldo A. Reyes T.
Coordinator of Development and Research
Saint Thomas Hospital, Panama