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临床试验/NCT04258878
NCT04258878Unknown不适用

Prospective Cohort Study in Evaluation of Risk Factors for Infection During and After Coronary Graft Operations.

Assiut University0 个研究点目标入组 100 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
surgical wound infection

研究概览

简要总结

We aim to prospectively evaluate the risk factors that can play a role before, during or after the surgical period.

详细描述

Surgical site infections (SSIs) are either superficial or deep and may involve the organs, or spaces accessed during an operation. The reported incidence of SSIs in coronary artery bypass grafting (CABG) surgery ranges between 0.3% and 8%.

There is a strong suggestion that an impairment of vascular supply of the sternum may be one of the most important factors influencing the incidence of deep sternal wound infection (DSWI). Several studies have studied the risk factors for SSIs including DSWI in cardiac surgery. These risk factors included obesity, diabetes mellitus, chronic obstructive pulmonary disease (COPD), connective tissue disease, steroid use, smoking, peripheral vascular disease and renal insufficiency. In addition, intraoperative factors (e.g., use of bilateral internal mammary arteries [BIMA] grafting, prolonged cardiopulmonary bypass [CPB] duration) and postoperative variables (e.g., prolonged mechanical ventilation, reoperation for bleeding, postoperative transfusions and gastrointestinal, nephrological and respiratory complications) have been shown to be associated with DSWI.

The risk for sternal wound infection (SWI) is increased if cardiac surgery involves internal thoracic arteries grafting and a valve procedure, or use of a ventricular assist device.

Leg wound infections at donor sites account for >70% of cases with severe infection following cardiac surgery.

Cardiac SSIs increase the length of hospital stay (LOS) and increase treatment costs in proportion to the severity of the infection. These costs increase by 3.8%, 14.7% and 29.4% in mild, moderate and severe infections respectively.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient aged more than 18 yards old
  • sternotomy for: coronary artery bypass,

排除标准

  • patient under age or 18years old.
  • patient who has endocarditis.
  • patient who underwent surgery with prothetic material, within the 12 months preceeding cardiac procedure.

结局指标

主要结局

surgical wound infection

时间窗: baseline

Evaluate the duration of complete healing of the sternum :By 1. Radiological (chest x-ray ant-post view and lat view in first 3 weeks post-operative 2. Clinical examination in first 3 weeks post operative

次要结局

  • Evaluation of perioperative risk factors for surgical wound infection in cardiac surgery(baseline)

研究者

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

Mohammed Hussein Rushdi

Dr

Assiut University

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