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.
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.
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).
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.
Cohort
Prospective
Not listed
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.
Cumulative incidence and timing of mesh-related infection
Cumulative incidence of mesh-related infection over the full follow-up period, and the timing (days from surgery) of each confirmed event, summarised by time-to-event methods.
Microbiology of mesh-related infection
Distribution of causative micro-organisms isolated from peri-mesh specimens among participants with confirmed mesh infection
Management of mesh infection: salvage versus explantation
Proportion of confirmed mesh infections managed by successful mesh salvage (non-operative/conservative measures) versus partial or complete mesh explantation.
Incidence of surgical site occurrence (SSO)
Proportion of participants with any surgical site occurrence (seroma, haematoma, surgical site infection, wound dehiscence, skin/soft-tissue necrosis, or enterocutaneous fistula) per the Ventral Hernia Outcomes Collaboration definitions.
Click on the lead sponsor to view all of their trials.
