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Risk Factors for Mesh Infection After Abdominal Wall Reconstruction

NCT07725718 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 420

Last updated 2026-08-18

No results posted yet for this study

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.

Conditions

  • Incisional Hernia
  • Ventral Hernia
  • Parastomal Hernia
  • Abdominal Wall Defect
  • Surgical Wound Infection
  • Prosthesis-Related Infections (Mesh Infection)

Sponsors & Collaborators

  • Minia University

    lead OTHER

Principal Investigators

  • Saleh K Saleh, MD · Minia University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2027-11-15
Completion
2028-08-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07725718 on ClinicalTrials.gov