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RECRUITING
NCT07725718

Risk Factors for Mesh Infection After Abdominal Wall Reconstruction

Sponsor: Minia University

View on ClinicalTrials.gov

Summary

Abdominal wall reconstruction (AWR) with mesh is the standard repair for ventral, incisional, parastomal and complex abdominal wall defects, but mesh-related infection remains one of its most serious complications - prolonging hospital stay, often requiring reoperation or removal of the mesh, and increasing the risk of hernia recurrence. Reported infection rates vary widely, and the independent contribution of individual risk factors remains uncertain, in large part because much of the existing evidence comes from retrospective series with inconsistent outcome definitions. This single-centre, prospective observational cohort study will enrol consecutive adults undergoing elective or urgent AWR with synthetic, biosynthetic or biological mesh at a tertiary referral hernia unit. Participants will be followed for 12 months on a fixed schedule (7-10 days, 30 days, 90 days, 6 months and 12 months). Using internationally accepted, prespecified definitions of mesh infection and surgical site occurrence, the study will collect up to 18 candidate patient, defect, operative and perioperative risk factors and analyse them by multivariable logistic regression to identify the independent predictors of mesh-related infection within 90 days of surgery. Secondary aims are to describe the incidence, timing, microbiology and management (salvage versus explantation) of mesh infection; to report surgical site occurrences and reoperation; and to derive an exploratory risk-stratification model. The findings are intended to support preoperative risk assessment, targeted patient optimisation, informed mesh and technique selection, and shared decision-making. The study is designed and reported in accordance with the STROBE statement.

Official title: Risk Factors for Mesh-Related Infection in Abdominal Wall Reconstruction: A Single-Centre Prospective Observational Cohort Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

420

Start Date

2026-08-15

Completion Date

2028-08-15

Last Updated

2026-08-18

Healthy Volunteers

No

Locations (1)

Minia University Hospitals - Department of Surgery, Faculty of Medicine, Minia University

Minya, Minya Governorate, Egypt