- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07790952
Predictors of Mesh Infection After Open Incisional Hernioplasty
Study Overview
Status
Conditions
Detailed Description
This prospective observational study will evaluate predictors of mesh infection following open incisional hernioplasty. Eligible patients with incisional hernia undergoing open mesh repair will be consecutively enrolled at the Department of Surgery, Dr. Faisal Masood Teaching Hospital, Sargodha. Demographic, clinical, anthropometric, and relevant perioperative factors will be recorded using a structured data collection form.
Patients will be followed postoperatively at 1 month, 3 months, and 1 year to assess the development of mesh infection and other related outcomes. Patients who develop mesh infection will be compared with those who remain infection-free to identify significant predictors. Data will be analyzed using SPSS version 26, with appropriate statistical tests and logistic regression to determine independent predictors of mesh infection.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Punjab Province
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Sargodha, Punjab Province, Pakistan, 40100
- Dr Faisal Masood teaching Hospital Sargodha
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All age group patient will be included
- Both genders will be involved in this study
- Incisional hernia as per operational definition
Exclusion Criteria:
- Co- Morbid condition including hypertension, Tuberculosis and Autoimmune disease
- Parents refusing for consent
- Immunocompromised patient
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Mesh infection
Participants undergoing open Incisional hernioplasty who develop mesh related infection during the postoperative followup period
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number and percentage of participants with Mesh related infection following open Incisional hernioplasty
Time Frame: 1 month, 3 months and 1 year after surgery
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Development of mesh related infection following open Incisional hernioplasty assessed during postoperative followup will be accessed by clinical examination of the surgical site.
The outcome will be measured as the number of participants who developed mesh related infection and percentage of mesh related infection.
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1 month, 3 months and 1 year after surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SMC-GS-2026-012
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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