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

NCT07049614 | Active Not Recruiting DMC

• 1 other identifier: MSAHSW/Batch-Fall23/913
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• Self administered questioner for data

  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.

  12 Months

Study Arms (2)

Diabetic Patients

Diagnostic Test: Diabetic Patients

Non-Diabetic Patients

Diagnostic Test: Non-Diabetic Patients

Interventions

Diabetic Patients DIAGNOSTIC_TEST

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.

Diabetic Patients

Non-Diabetic Patients DIAGNOSTIC_TEST

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

Non-Diabetic Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. Diabetes mellitus is a well-known risk factor for delayed wound healing and postoperative complications

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

DHQ Hospital

Dera Ismāīl Khān, Khyber Pakhtunkhwa, Pakistan

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: March 17, 2025
• Primary Completion: September 1, 2025
• Study Completion: February 28, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)