Surgical Site InfectionNCT07049614
Comparative Study of Postoperative Surgical Site Infections in Diabetic and Non-Diabetic Patients
An observational study of Surgical Site Infection, run by Superior University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Diabetic Patients and Non-Diabetic Patients
- How many people
- 132 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Mar 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Postoperative Surgical Site Infections in Diabetic and Non-Diabetic Patients Undergoing General Surgical Procedures
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.
Read the 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
- Being tested
- Diabetic Patients, Non-Diabetic Patients
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetic PatientsDiagnostic 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 PatientsDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Patients | Not described Receives: Diagnostic Test: Diabetic Patients | |
| Non-Diabetic Patients | Not described Receives: Diagnostic Test: Non-Diabetic Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start17 Mar 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049614
- Sponsor's protocol ID
- MSAHSW/Batch-Fall23/913
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Postoperative Surgical Site Infections in Diabetic and Non-Diabetic Patients Undergoing General Surgical Procedures
- ClinicalTrials.gov ID
- NCT07049614
- Acronym / sponsor ID
- MSAHSW/Batch-Fall23/913
- Conditions
- Surgical Site Infection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic Patients | – | Diagnostic Test: Diabetic Patients |
| Non-Diabetic Patients | – | Diagnostic Test: Non-Diabetic Patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetic PatientsThis 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 | Diabetic Patients |
| Non-Diabetic PatientsThis 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 | Diagnostic test | Non-Diabetic Patients |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self administered questioner for data (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.