Subcutaneous Drain Versus Wound Irrigation by Normal Saline for Prevention of Surgical Site Infection Following Caesarean Section in Obese Patients: A Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Incidence of surgical site infection
研究概览
简要总结
This is a prospective randomized controlled trial conducted at Ain Shams University Maternity Hospital to compare subcutaneous drain versus wound irrigation with normal saline for the prevention of surgical site infection following cesarean section in obese patients. Eligible women were randomly assigned to either subcutaneous drain placement or intraoperative wound irrigation, or subcutaneous skin closure only. The primary outcome was the incidence of surgical site infection, with additional assessment of postoperative wound complications and recovery.
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
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Obese Pregnant women who attend for cesarean section.
- •Aged 18 to 50 years old.
- •BMI ≥ 30 kg/m2.
排除标准
- •Preoperative uncontrolled infection.
- •Prolonged premature rupture of membranes.
- •Severe surgical blood loss >1000ml.
- •Uncontrolled Pregestational Diabetes mellitus type 1 and type
- •Uncontrolled Gestational Diabetes mellitus.
- •Uncontrolled Hypertension with pregnancy.
- •Preeclampsia and Eclampsia, Pregnancy-induced hypertension (PIH).
- •Chronic medical disorders including chronic kidney disease, chronic hepatitis, chronic autoimmune disease and chronic heart disease.
- •Anemia with pregnancy.
- •Patient with Immunodeficiency disorders and patients on immunosuppressive drugs.
- •Patient with recent history of drug abuse.
研究组 & 干预措施
Subcutaneous Drain group
A Drain is put subcutaneously to drain any excess fluid
干预措施: Subcutaneous Drain (Procedure)
Wound irrigation group
The wound is irrigated with Normal saline before wound closure intraoperatively.
干预措施: Normal Saline (Procedure)
Only Subcutaneous closure
Subcutaneous closure with vicryl with no additional intervention.
结局指标
主要结局
Incidence of surgical site infection
时间窗: 10 days
Assessment of surgical site infection according to standard clinical criteria following cesarean section in the study groups.
次要结局
- Wound complications(6 weeks)