CTRI/2017/02/007790已完成不适用
Effect Of Antibiotic Prophylaxis In Patients Undergoing Modified Radical Mastectomy - A Randomized Double-Blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- JIPMER
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Rate of Surgical Site Infection according to CDC definition
研究概览
简要总结
| Surgical site infection (SSI) is a major source of adverse operation-related event in patients undergoing surgery, including increased morbidity, additional cost and delay of postoperative adjuvant therapies. Till date no single study has been done exclusively defining the role of antibiotic prophylaxis in patients undergoing modified radical mastectomy (MRM) in India.The aim of this randomized clinical trial is to determine whether prophylactic antibiotics are indicated in patients undergoing MRM and to identify the risk factors that increase the rate of post operative SSI. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •PATIENTS WHO ARE DIAGNOSED CASES OF CARCINOMA BREAST WHO ARE PLANNED TO UNDERGO MODIFIED RADICAL MASTECTOMY AS DECIDED BY THE INSTITUTE TUMOR BOARD.
排除标准
- •Exclusion criteria
- •Hypersensitivity to intravenous Cefazolin 2.Patients receiving antibiotics for some other reason 3.Patients with local skin infections at the site of surgery 4.Patients on steroids 5.Immunosuppressive disease(HIV).
结局指标
主要结局
Rate of Surgical Site Infection according to CDC definition
时间窗: 30 Days
次要结局
- Detecting potential risk factors in the development of surgical site infection(30 Days)
研究者
研究点 (1)
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