Comparing the efficacy of Chlorhexidine Gluconate Versus Povidone-Iodine as Skin Antiseptic for prevention of Surgical Site Infection in women undergoing emergency Caesarean Delivery: A Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 876
- 试验地点
- 1
- 主要终点
- To estimate the incidence of surgical site infection with use of Chlorhexidinegluconate compared with povidone iodine as skin antiseptic in women undergoing emergency caesarean delivery.
研究概览
简要总结
This study is a randomized, double blind, parallel group, active controlled trial comparing the efficacy of chlorhexidine gluconate and povidone iodine as skin antiseptic for prevention of surgical site infection in women undergoing emergency caesarean delivery expecting chlorhexidine–gluconate to be superior to povidine iodine in having less incidence of SSI. The primary outcome measures will be the incidence of Surgical Site Infection. The secondary outcome measures will be the duration of hospital stay, requirement for re-suturing, re-admission resulting from infection, pyrexia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 39.00 Year(s)（—）
- 性别
- Female
入选标准
- •Antenatal women at ≥34 weeks gestational age undergoing emergency Cesarean delivery.
排除标准
- •Patients denying consent 2)Known allergy to one or both of the agents.
- •Patients with skin lesions adjacent to the operative site.
- •Women with chorioamnionitis, pyelonephritis, urinary tract infection, and mastitis.
结局指标
主要结局
To estimate the incidence of surgical site infection with use of Chlorhexidinegluconate compared with povidone iodine as skin antiseptic in women undergoing emergency caesarean delivery.
时间窗: followed postoperatively after 48 hours,1 week and 30 days.
次要结局
- To compare the incidence of the below outcomes(1)Duration of hospital stay.)