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临床试验/CTRI/2023/09/058027
CTRI/2023/09/058027招募中2 期

An academic study of the investigation of digital biomarkers for early detection of surgical site infections

Madras Medical College1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年3月10日最近更新:

试验速览

阶段
2 期
状态
招募中
入组人数
200
试验地点
1
主要终点
To collect objective and quantifiable digital biomarker data continuously from the surgical site of patients who have undergone elective or emergency laparotomy, to develop early warning algorithms to detect and predict the likelihood of SSIs

研究概览

简要总结

Surgical site infections (SSIs) account for 20% of the estimated two million nosocomial infections. Although the global estimates of SSI are diverse, studies in India have consistently shown higher rates ranging from 23% to 38%. The incidence of SSI is as high as 15-25% after an abdominal surgery as compared to other surgeries and is largely dependent on the level of contamination during surgery. Suchitra et al conducted a prospective study in India and observed that surgeries such as gastrectomy, hysterectomy, cholecystectomy and appendectomy were associated with a higher risk of SSI. Jacobs et al reported a 30-day readmission of 22% for patients undergoing major abdominal surgery, with 47% of readmissions occurring within 1 week of discharge.As the symptoms and signs of SSIs mimic ‘normal’ recovery, they are detected usually after the infection is firmly established. This leads to complications such as, the need for re-entry of the wound; when severe, this can lead to sepsis, organ failure, and death. The prevalence of SSI is often underestimated because SSIs frequently present after the patient is discharged. We hypothesize that the early warning risk scores calculated using the novel medical device is linked to the pathobiology of wound healing and will be predictive of SSIs in patients who have undergone elective or emergency laparotomy or gastrointestinal surgery for benign or malignant disease.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients who are undergoing elective or emergency laparotomy or undergoing gastrointestinal surgery for benign and malignant conditions 2.18-80 years of age at the time of admission.

排除标准

  • 1.Subjects who are diagnosed of communicable diseases and are a risk for biohazard 2.Subjects with preoperative sepsis.

结局指标

主要结局

To collect objective and quantifiable digital biomarker data continuously from the surgical site of patients who have undergone elective or emergency laparotomy, to develop early warning algorithms to detect and predict the likelihood of SSIs

时间窗: Day of Surgery to 30 days post-discharge

次要结局

  • Remotely monitor the surgical wound during the post-operative period using a novel medical device(Day of Surgery to Discharge from hospital)

研究者

申办方类型
Government medical college

研究点 (1)

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