Comparative Study of Postoperative Surgical Site Infections in Diabetic and Non-Diabetic Patients Undergoing General Surgical Procedures
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Self administered questioner for data
研究概览
简要总结
This prospective observational study aims to compare the incidence and characteristics of postoperative surgical site infections (SSIs) between diabetic and non-diabetic patients undergoing elective general surgical procedures.
详细描述
Diabetes mellitus is a well-known risk factor for delayed wound healing and postoperative complications. The study seeks to identify how diabetic status influences SSI rates, types (superficial, deep, organ/space), and associated risk factors such as glycemic control (HbA1c), duration of diabetes, and presence of comorbidities.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female patients aged 18 to 80 years.
- •Patients undergoing elective general surgical procedures.
- •Patients diagnosed with diabetes mellitus (Type 1 or Type 2), whether on oral hypoglycemics or insulin, with satisfactory preoperative glycemic control.
- •Patients willing to give informed consent.
- •Patients available for postoperative follow-up on Day 1, 7, and 14.
排除标准
- •Emergency surgical cases.
- •Patients with gestational diabetes.
- •Patients with poorly controlled diabetes preoperatively.
- •Patients with severe comorbid conditions, such as ischemic heart disease, peripheral vascular disease, neuropathy, active cancer, or immunocompromised states (e.g., HIV/AIDS).
- •Patients on immunosuppressive therapy.
- •Patients below 18 years of age.
结局指标
主要结局
Self administered questioner for data
时间窗: 12 Months
A structured questionnaire developed for this study will record demographic data (age, gender, BMI), medical history (diabetes status, duration, HbA1c levels, comorbidities), lifestyle factors (smoking status), surgical details (type of surgery, surgical approach, duration of surgery), and postoperative outcomes (SSI presence, type, day of onset, management). Scoring/Recording: Diabetes status: Diabetic / Non-Diabetic HbA1c Level: Recorded as a percentage (%) Presence of SSI: Yes / No Type of SSI: Superficial Incisional SSI. Deep Incisional SSI. Organ/Space SSI. Postoperative Complications: Sepsis, wound dehiscence, organ dysfunction (marked Yes/No). Hospital stay: Recorded in number of days.
次要结局
未报告次要终点
研究者
Muhammad Naveed Babur
Principal Investigator
Superior University