Closure Versus Non Closure of Subcutaneous Tissue After Cesarean Section in Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 主要终点
- Number of participants with 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 the patient's satisfaction for closure of subcutaneous tissue versus non closure of subcutaneous tissue after cesarean delivery in women with diabetes mellitus.
详细描述
This is a randomized prospective comparative clinical study will be conducted in Ain Shams University, Maternity Hospital.
This study will include a sample of (136) pregnant women with gestational diabetes mellitus and type 2 diabetes mellitus who underwent elective Cesarean section.
Patients will b divided into two groups:
Group A (closure group): will include 68 pregnant women who underwent elective Cesarean section with closure of subcutaneous tissue. Group B (non closure group): will include 68 pregnant women who underwent elective Cesarean section without closure of subcutaneous tissue.
• All participants in the study will have consent.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women in childbearing period (18-45 years).
- •Women planned for elective cesarean section.
- •Pregnant women with gestational diabetes according to medical records.
排除标准
- •Hemoglobin less than 10g/dl.
- •Intra operative events that may themselves predispose to postoperative infection (e.g. operative time more than 90 minutes).
- •Rupture of membrane more than 12 hours.
- •Receive corticosteroid medications.
- •Immunosuppressive disease or Auto immune disease.
- •Concurrent infection (e.g. signs of pyelonephritis, chest infection).
- •Previous history of two C.S.
- •Previous laparotomy other than C.S.
结局指标
主要结局
Number of participants with surgical site infection
时间窗: 9 months
Surgical site infection: including the following manifestations: Collection; inflammatory signs (pain, tenderness, edema, redness); dehiscence (wound separation) or positive culture.
次要结局
- Number of participants with cosmetic wound(1 month)
- Number of participants with postoperative pain(24 hours)
- Number of participants with postoperative fever(48 hours)
- Number of participants with wound seroma(month)
研究者
Rehab Mohamed Abdelrahman
Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University
Ain Shams University