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临床试验/CTRI/2020/07/026302
CTRI/2020/07/026302已完成不适用

COMPARISON OF EFFECT OF CEFTRIAXONE IN-FILTRATION BEFORE INCISION AND BEFORE CLOSURE IN LAPAROTOMY FOR PERFORATION PERITONITIS –A RANDOMIZED CONTROL STUDY.

MAULANA AZAD MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年7月27日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Effect of ceftriaxone infiltration before incision and before closure in preventing SSI

研究概览

简要总结

Surgical site infection (SSI) continues to be a baffling problem. It is one of the major causes for postoperative morbidity and mortality. Over the years, reasonable success has been achieved in this direction by taking various aseptic measures, which were initiated by Joseph Lister  in 1860.

1 Initially, the antibiotics were only administered post-operatively for treatment of already established surgical site infection.

2 Later, the concept of antibiotic prophylaxis was introduced. After administration of intravenous (IV) antibiotic, there is distribution of antibiotics, initially in the systemic pool and then in the peripheral pool, which results in a low concentration of the antibiotic at the site where it is needed the most.

3 Therefore, the search for alternative modes of administration of prophylactic antibiotics was started so as to affect a further decrease in the rate of woundinfection. One such method is the intra-incisional infiltration of prophylactic antibiotics. This mode ensures a high concentration of antibiotic at the incision site and it has been proven to provide systemic cover by the absorption of the antibiotic from the incision site. Ceftriaxone an antibiotic with long half-life, was chosen because of its known effectiveness against a wide range of wound pathogens, including obligate anaerobes, at concentrations likely to be present locally. This study is done to evaluate the role of intra incisional infiltration of ceftriaxone in prevention of SSI.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • All patients diagnosed with perforation peritonitis.

排除标准

  • Diabetes Mellitus.
  • On immunosuppresive therapy.
  • BMI > 35 Kg/m2 Sensitivity to ceftriaxone.
  • Previous midline abdominal surgery.

结局指标

主要结局

Effect of ceftriaxone infiltration before incision and before closure in preventing SSI

时间窗: Effect of ceftriaxone infiltration before incision and before closure in preventing SSI on postoperative day 7.

次要结局

  • Duration of hospital stay.(Time duration)

研究者

申办方类型
Government medical college

研究点 (1)

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