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

NCT ID: NCT07049614

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-17

Study Completion Date

2026-02-28

Brief Summary

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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

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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

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Surgical Site Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Diabetic Patients

Diabetic Patients

Intervention Type 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

Non-Diabetic Patients

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Superior University

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Naveed Babur

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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DHQ Hospital

Dera Ismāīl Khān, Khyber Pakhtunkhwa, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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MSAHSW/Batch-Fall23/913

Identifier Type: -

Identifier Source: org_study_id

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