Risk Factors for Mesh Infection After Abdominal Wall Reconstruction

NCT07725718 | Not Yet Recruiting DMC

• 1 other identifier: 2057:7/2026
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

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

Keywords

Mesh infection; Abdominal wall reconstruction; Surgical site occurrence (SSO); SSO requiring procedural intervention (SSOPI); Risk factors; Prosthetic mesh; Component separation / transversus abdominis release; Hernia recurrence; Surgical site infection

Outcome Measures

Primary Outcomes (1)

• Incidence of mesh-related infection within 90 days of abdominal wall reconstruction

  Proportion of participants with mesh-related infection, defined as infection involving the implanted mesh confirmed by at least one of: purulent drainage from the wound or a peri-mesh space in contact with the prosthesis; positive microbiological culture from peri-mesh fluid, the explanted mesh, or an image-guided/operative peri-mesh specimen; cross-sectional imaging (preferably contrast-enhanced CT) demonstrating a peri-mesh collection or abscess with clinical signs of infection; or the need for operative or percutaneous intervention directed at infected mesh, including partial or complete explantation for infection.

  Within 90 days after surgery

Secondary Outcomes (9)

• Cumulative incidence and timing of mesh-related infection

  Through 12 months after surgery

• Microbiology of mesh-related infection

  Through 12 months after surgery

• Management of mesh infection: salvage versus explantation

  Through 12 months after surgery

• Incidence of surgical site occurrence (SSO)

  30 days, 90 days and 12 months after surgery

• Incidence of SSO requiring procedural intervention (SSOPI)

  30 days, 90 days and 12 months after surgery

Study Arms (1)

Abdominal wall reconstruction with mesh

Consecutive adults (≥18 years) undergoing elective or urgent abdominal wall reconstruction with synthetic, biosynthetic or biological mesh for a ventral, incisional, parastomal or complex abdominal wall defect, enrolled at the time of surgery and followed prospectively for 12 months. No study-specific intervention is imposed; management follows routine unit practice.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adults (≥18 years) undergoing elective or urgent abdominal wall reconstruction with synthetic, biosynthetic or biological mesh for a ventral, incisional, parastomal or complex abdominal wall defect at a single tertiary referral hernia and abdominal wall surgery unit.

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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

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

Minya, Minya Governorate, 61519, Egypt

Location

MeSH Terms

Conditions

Incisional Hernia; Hernia, Ventral; Surgical Wound Infection; Prosthesis-Related Infections

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Hernia, Abdominal; Wound Infection; Infections

Study Officials

• Saleh K Saleh, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh K Saleh, MD

CONTACT

01201765401; salehkhairy@mu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of General Surgery, Department of Surgery, Faculty of Medicine

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): August 15, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)