Comparative Study of Postoperative Surgical Site Infections in Diabetic and Non-Diabetic Patients
- Conditions
- Surgical Site Infection
- Registration Number
- NCT07049614
- Lead Sponsor
- Superior University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 132
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Self administered questioner for data 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
DHQ Hospital
🇵🇰Dera Ismāīl Khān, Khyber Pakhtunkhwa, Pakistan
DHQ Hospital🇵🇰Dera Ismāīl Khān, Khyber Pakhtunkhwa, Pakistan