Subcutaneous Tissue Irrigation With Povidone Iodine in Decreasing the Rate of Surgical Site Infection Following Cesarean Section (Randomized Control Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Surgical site infection up to 14 days following elective caesarian section.
研究概览
简要总结
This study aims to assess the efficacy of Povidone Iodine (Betadine®) irrigation of subcutaneous tissue prior to skin closure in reducing the incidence of surgical site infection after elective caesarean section and post discharge.
详细描述
All women will be counseled regarding mode of intervention and informed consent will be obtained. All women will be subjected to complete history taking, routine antenatal examination and investigations especially Hemoglobin test and 2 hour glucose tolerance test, treatment of genital or urinary tract infections if diagnosed. Routine obstetric ultrasound examination.
Primary Outcome :
Surgical site infection up to 14 days following elective caesarian section.
Criteria of Surgical site infection:
Infection involves only skin and subcutaneous tissue of this incision. Occurs within 14 days after the operative procedure.
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: from 20 to 35 old years.
- •Elective cesarean section.
- •Caesarean section time from skin incision to skin closure less than 60 minutes.
- •Preoperative Hemoglobin more than 10 gm /dl.
- •Body Mass Index: 20_30 Kg/m2 .
排除标准
- •Body Mass Index: <20 or >30 Kg/m
- •Diabetic patient.
- •Feverish patient.
- •Patient using steroids for chronic illness.
- •Hypertension chronic or with pregnancy.
- •Prelabour rupture of membranes.
- •Difference in pre and postoperative hemoglobin more than 10%.
- •Patients have a Coagulopathy disorder.
- •Multiple pregnancy.
研究组 & 干预措施
Povidone irrigation Group
Includes the 100 women who will undergo elective caesarian section with subcutaneous tissue irrigation with Povidone iodine 1% solution.
干预措施: Povidone iodine 1% solution (Drug)
结局指标
主要结局
Surgical site infection up to 14 days following elective caesarian section.
时间窗: 14 Days
* Infection involves only skin and subcutaneous tissue of this incision. * Occurs within 14 days after the operative procedure. * Includes at least one of the following: 1. purulent drainage is present (culture documentation not required) 2. organisms are isolated from fluid/tissue of the superficial incision 3. at least one sign of inflammation (eg, pain or tenderness, induration, erythema, local warmth of the wound) is present. 4. the wound is deliberately opened by the surgeon 5. the surgeon or clinician declares the wound infected.
次要结局
未报告次要终点
研究者
George Adel Azmy
Specialist in Obstetrics and Gynecology
Ain Shams University