Comparative Study of Postoperative Surgical Site Infections in Diabetic and Non-Diabetic Patients
NCT ID: NCT07049614
Last Updated: 2025-07-03
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
132 participants
OBSERVATIONAL
2025-03-17
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Diabetic Patients
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.
Non-Diabetic Patients
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
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.
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Superior University
OTHER
Responsible Party
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Muhammad Naveed Babur
Principal Investigator
Locations
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DHQ Hospital
Dera Ismāīl Khān, Khyber Pakhtunkhwa, Pakistan
Countries
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Other Identifiers
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MSAHSW/Batch-Fall23/913
Identifier Type: -
Identifier Source: org_study_id
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