Risk Factors for Mesh Infection After Abdominal Wall Reconstruction

Starting soon

Conditions studied: Incisional Hernia, Ventral Hernia, Parastomal Hernia, Abdominal Wall Defect, Surgical Wound Infection, Prosthesis-Related Infections (Mesh Infection)

In brief

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.

Key facts

Study ID

NCT07725718

Run by

Minia University

People needed

420

Starts

2026-08-15

Expected to finish

2028-08-15

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged ≥18 years.
• Undergoing elective or urgent abdominal wall reconstruction with implantation of synthetic, biosynthetic or biological mesh for a ventral, incisional, parastomal or complex abdominal wall defect.
• Able and willing to provide written informed consent and to attend scheduled follow-up.

You may not qualify if…

• Suture-only repair without mesh.
• Inguinal or femoral (groin) hernia repair.
• Active systemic sepsis or established intra-abdominal mesh infection at the time of index surgery.
• Mesh placed solely for a non-reconstructive indication (e.g. temporary abdominal closure or planned re-look without definitive reconstruction).
• Estimated life expectancy < 12 months or inability to complete the minimum follow-up.
• Patient declines participation.

Where it is running

• Minia University Hospitals - Department of Surgery, Faculty of Medicine, Minia University — Minya, Minya Governorate, Egypt

Full record on ClinicalTrials.gov

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