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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

DHQ Hospital

Dera Ismāīl Khān, Khyber Pakhtunkhwa, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

Self administered questioner for data

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Jul 3, 2025
Registry last updated: Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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