跳至主要内容
临床试验/NCT03114332
NCT03114332已完成不适用

Subcutaneous Drains In Lean Women Undergoing Cesarean Section, A Randomized Controlled Trial

Menoufia University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年12月最近更新:
适应症
干预措施

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

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

Experimental

Patients for whom a subcutaneous drain was used

干预措施: Subcutaneous Drain (Procedure)

Control group

No Intervention

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Haitham Aboali Hamza

Lecturer of Obstetrics and Gynecology

Menoufia University

研究点 (2)

Loading locations...

相似试验

Subcutaneous Drains And Cesarean Section | 临床试验