Comparative Study of Postoperative Surgical Site Infections in Diabetic and Non-Diabetic Patients

Superior University

Status: Active, not recruiting

Conditions: Surgical Site Infection

Treatments: Diagnostic Test: Diabetic Patients; Diagnostic Test: Non-Diabetic Patients

Study type: Observational

Funder types: Other

Identifiers

NCT07049614

MSAHSW/Batch-Fall23/913

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

132 participants in 2 patient groups

Diabetic Patients

Treatment:

Diagnostic Test: Diabetic Patients

Non-Diabetic Patients

Treatment:

Diagnostic Test: Non-Diabetic Patients