NCT07049614

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 132 (actual)
• Sponsor: Superior University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diabetic Patients	This group consists of 66 adult diabetic patients (Type 1 or Type 2) undergoing elective general surgical procedures. These patients will be managed as per standard clinical protocols, including preoperative evaluation, glycemic control assessment (via recent HbA1c and blood glucose levels), and administration of prophylactic broad-spectrum antibiotics-typically second-generation cephalosporins and metronidazole. Postoperative follow-up will be conducted on Day 1, Day 7, and Day 14 to monitor for the development of surgical site infections (SSIs), which will be classified by the unit chief as superficial, deep, or organ/space infections.
DIAGNOSTIC_TEST	Non-Diabetic Patients	This group includes 66 adult non-diabetic patients undergoing elective general surgical procedures at DHQ Hospital, Dera Ismail Khan. These participants will serve as the comparison group for evaluating the incidence and characteristics of postoperative surgical site infections (SSIs). All patients will receive standard preoperative assessments and prophylactic antibiotics (second-generation cephalosporins with metronidazole) as per institutional protocols. Postoperative follow-up will be carried out on Day 1, Day 7, and Day 14, and SSIs, if any, will be classified based on CDC criteria into superficial, deep, or organ/space infections

Timeline

• Start date: 2025-03-17
• Primary completion: 2025-09-01
• Completion: 2026-02-28
• First posted: 2025-07-03
• Last updated: 2025-07-03

Locations

1 site across 1 country: Pakistan