The Impact of Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- surgical site infection
研究概览
简要总结
the aim of this study is to evaluate the efficacy of employing cefepime (CFM) versus ampicillin/sulbactam (AMS) in lowering the rate of post-cesarean surgical site infections.
详细描述
A prospective randomized clinical study conducted in the department of obstetrics and gynecology of Beni-Suef University Hospital . A total of 213 women were assessed for eligibility, 13 of which were excluded. A total of 200 pregnant women who were eligible for elective cesarean sections (CS). The overall median duration of postoperative followed up was from 10 days to one month to determine the surgical site infection (SSI).
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women within age group more than18 years.
- •Pregnant women with elective cesarean delivery.
- •Previous and primary cesarean delivery.
排除标准
- •Severe hepatic disease women Emergent cesarean deliveries. Women with medical disorders as pre-gestational diabetes, anemia, hypertension, or preeclampsia.
- •Women who had a skin infection adjacent to the operative site.
研究组 & 干预措施
Cefepime Group
Pregnant women (n=100) received IV cefepime (CEF) (maxipime®1000mg) 30 minutes before cesarean delivery (CD) and 12 hours after CD
干预措施: Cefepime 1000 MG (Drug)
Ampicillin/Sulbactam
Pregnant women (n=100) received IV Ampicillin/Sulbactam (AMS) (Unictam® 1500 mg) 30 minutes before CD and 12 hours after CD
干预措施: Ampicillin-sulbactam (Drug)
结局指标
主要结局
surgical site infection
时间窗: 1 month
pain, redness, swelling, warm skin around the wound, yellow or green discharge
次要结局
未报告次要终点
研究者
Sara Abdallah Mohamed Salem
principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Beni-Suef University