Surgical Site Infection Rates of Two Different Skin Closure Methods Used in Obese Patients After Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 主要终点
- Surgical site infection
研究概览
简要总结
The aim of this study is to determine the surgical site infection rate and patient satisfaction for subcuticular versus interrupted mattress suture in closure of skin at Cesarean delivery in obese patients.
详细描述
This is a randomized controlled trial conducted in Ain-Shams University Maternity Hospital on the period from March 2012 till August 2012. It included 130 pregnant women who underwent elective Cesarean section.
The aim of this study is to determine the surgical site infection rate and patient satisfaction for subcuticular versus interrupted mattress suture in closure of skin at Cesarean delivery in obese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: any female in childbearing period.
- •Women planned for elective Cesarean section.
- •Obese women (BMI ≥ 30 Kg/m2). Our study calculated the BMI of patients from their weight and height at admission, because the pre-pregnancy BMI was not available for all patients, and we hypothesized that the BMI at admission was a better indicator of body mass during the at-risk time for development of SSI than was the pre-pregnancy BMI.
排除标准
- •Women who had concurrent overt infection (e.g.chorioamnionitis, pyelonephritis or chest infection).
- •Women who had intraoperative events that may themselves predispose to perioperative infection (e.g. bowel injury, operative time more than 90 minutes, major blood loss).
- •Women who had hemoglobin less than 10g/dl, preeclampsia, diabetes, rupture of membranes more than 12 hours, corticosteroid therapy.
- •Patients who had non Pfannenstiel incision.
结局指标
主要结局
Surgical site infection
时间窗: 30 days after the operative procedure
We used the definition devised and adopted by the Center for Disease Control and Prevention.
次要结局
- Skin closure time(15 minutes)
- Postoperative pain(48 hours)
- Short-term cosmetic wound outcome(30 days)
- Overall women satisfaction(30 days)
研究者
Mohamed Ellaithy
Principal Investigator
Ain Shams University