A Randomised Trial to Evaluate the Efficacy and Feasibility of a Closing Pack to Reduce the Rate of Surgical Site Infection Following Caesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Efficacy to reduce surgical site infections within seven days
研究概览
简要总结
Randomised trial comparing the efficacy and feasibility of using a sterile closing pack to reduce postpartum sepsis
详细描述
Pregnant patients meeting the inclusion criteria undergoing elective or emergency caesarean section will be eligible for recruitment. Patients will be randomised into two arms. In the control arm sheath and skin closure will be performed with the instruments used to perform the caesarean section, as per the current standard of care. In the intervention arm, after suturing the uterine incision and obtaining hemostasis and before commencing closure of the sheath and skin, the surgical team (obstetrician, assistant and scrub sister) will don clean sterile gloves, open clean sterile linen to drape on top of the existing linen and open a pack of clean sterile instruments to close the sheath and skin.
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
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will not have information with regards to the intervention arms
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women 18 years and older willing and able to provide consent
排除标准
- •women who are not able or willing to provide consent patients with existing maternal infection
结局指标
主要结局
Efficacy to reduce surgical site infections within seven days
时间窗: Seven days post-operatively
Incidence of surgical site infections in both arms
次要结局
- Feasibility of using a closure pack(At the time of caesarean section)
- Efficacy to reduce postpartum endometritis within seven days(Seven days post-operatively)
研究者
Leon Snyman
Prof
University of Pretoria