Subcutaneous Drains In Lean Women Undergoing Cesarean Section, A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Rate of superficial surgical site infection
研究概览
简要总结
A randomized controlled trial that aimed at studying the values (if any) of subcutaneous drains use in lean women during Cesarean section.
详细描述
Cesarean section (CS) is one of the most common operative procedures performed in modern obstetrics. Despite being that, common, surgical techniques and steps do widely vary. These variations depend on many factors including surgeons preferences, patient s characteristics and available facilities and circumstances .
The most common complications of Cesarean section are superficial surgical site complications including sepsis, seroma formation and breakdown.
One of the common, yet debatable, practices in Cesarean section is to use a subcutaneous drain for the wound .The advantage of such a practice is to drain any blood or serous fluid that may accumulate in the subcutaneous space, which cause post-operative pain or provide a good medium for microbial growth and infection.
Thus, it is assumed that drains can reduce the burden of surgical site infection. Some surgeons, however, have raised much argument about the value of subcutaneous drains and emerging evidence raised concerns about its effectiveness. Despite this, it is evident that it is still widely used in the clinical practice.
Most randomized controlled trials on this issue, from which we draw the current evidence, were conducted in the developed countries, mainly the United States, with readily available facilities and optimum level of care. This fact raises concerns about how this evidence can be applicable in developing countries with weak health care systems and low level of awareness. In addition, Cesarean section rates are greatly higher in developing countries due to its abuse, which emphasize how the current evidence can't be applicable and in need for further updates .
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
- 否
入选标准
- •All females with previous cesarean sections admitted to Obstetrics and Gynecology Department at Menoufia University Hospitals either for elective or urgent cesarean section will be considered eligible.
排除标准
- •In order to control any confounding variables, we will exclude women with an added risk of wound complications. Those will include:
- •Diabetic women (as determined by fasting blood sugar and 2-hour Post prandial blood glucose).
- •Morbid obese women (those with body mass index more than 35).
- •Smokers and alcoholics.
- •Immunocompromised women: AIDS patients and those receiving immunosuppressant agents.
研究组 & 干预措施
Study Group
Patients for whom a subcutaneous drain was used
干预措施: Subcutaneous Drain (Procedure)
Control group
No drain group
结局指标
主要结局
Rate of superficial surgical site infection
时间窗: within 72 hours after the operation
rate of superficial surgical site infection, defined as presence of wound discharge that yielded a positive result on bacteriological culture within 72 hours after the operation
次要结局
- Postoperative fever(24 hours postoperatively)
- Superficial wound breakdown(up to 6 weeks postoperative)
- Postoperative pain(after 24 hours postoperative)
- Wound seroma(up to 6 weeks postoperative)
研究者
Haitham Aboali Hamza
Lecturer of Obstetrics and Gynecology
Menoufia University
