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临床试验/NCT01679379
NCT01679379已完成不适用

Surgical Site Infection in Obese Women After Cesarean Section; A Randomized Controlled Trial of Absorbable Versus Non Absorbable Sutures for Skin Closure.

Ain Shams University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Surgical site infection

研究概览

简要总结

The purpose of this study is to determine the surgical site infection rate and patient satisfaction for absorbable versus non absorbable suture in closure of skin at cesarean section in obese women.

详细描述

Cesarean section (CS) is the commonest major operation performed on women in the world. Approximately one in 4 women in the United States is delivered by cesarean section, and it is well established that operative abdominal delivery is associated with a significant risk of infection compared with vaginal delivery. These risks are increased with preexisting operative site infection, breaks in sterile technique, prolonged preoperative admissions that may result in colonization with resistant microbes, prolonged operative duration, use of electrocautery, obesity, advanced age, inadequate host immunocompetence.

Obese women may have increased susceptibility to infections because of the effects of obesity on the immune system, skin barriers, wound healing, mobility, and coexisting chronic diseases including diabetes, which could increase infection risk by itself. Cohort studies have shown that women with a body mass index (BMI)>30kg/m^2 have a two to three folds increased risk of post cesarean infections, such as wound infection, urinary tract infection UTI), endometritis, or pneumonia, compared with non-obese women. Other studies found that obesity doubled the risk specifically for post-cesarean wound infection.

Wound complications are a major source of morbidity after CS and contribute to prolonged hospital stay and rates of readmission. Age, (BMI), length of incision, and timing of prophylactic antibiotic administration have all been associated with post cesarean surgical site infection (SSI).

A surgical site infection is an infection that occurs after surgery in the part of the body where the surgery took place. SSI can sometimes be superficial infections involving the skin only. Other surgical site infections are more serious and can involve tissues under the skin, organs, or implanted material. SSI has a great impact on the economy and health care resources. Infection has always been a feature of modern surgery and continues to be a significant problem for health care practitioners across the world.

The ideal skin closure would be safe and effective, associated with minimal patient discomfort, and have a good cosmetic result. It would also be inexpensive and require fewer health care resources by being fast and easy to apply, require minimal follow-up evaluation, and be associated with a low rate of complications.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant female in child bearing period
  • Mode of delivery is by cesarean section (CS)
  • Obese women, Body Mass Index (BMI) >30kg/m^2
  • Viable fetus
  • Gestational age >34 weeks

排除标准

  • Hemoglobin (Hb)less than 10g/dl.
  • Previous laparotomy other than CS.
  • Rupture of membranes for more than 12 hours.
  • Presence of signs of systemic or local infection on admission (e.g. fever, tender uterus).
  • Prolonged operative time >90 minutes.
  • Previous two CS or more.
  • Autoimmune disease.
  • Immune suppressive disease.
  • Corticosteroid medications.

结局指标

主要结局

Surgical site infection

时间窗: Within 30 days of surgery

Diagnosis consists of infection of an anatomic plane by one of the following manifestations: collection; inflammatory signs (pain, tenderness, edema, redness); dehiscence(Wound separation was defined as any separation of the wound that was identified as such by the patient or the medical record and varied in size from small skin defects to separation of the entire wound; or positive culture.

次要结局

  • Skin closure time(30 days)

研究者

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

Mohamed Ellaithy

Lecturer of Obstetrics & Gynecology

Ain Shams University

研究点 (1)

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