Complex Abdominal Wall Reconstruction With Polyvinylidene (PVDF) Mesh in the Setting of Active Infection: a Prospective Case-control Series.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 76
- Locations
- 2
- Primary Endpoint
- Surgical site infection
Study Overview
Brief Summary
The use of synthetic mesh to repair infected defects of the abdominal wall remains controversial. This study aimed to evaluate the short-term outcomes of using PVDF mesh to treat infected abdominal wall defects in the elective setting.
Detailed Description
From May 2016 until February 2021, 38 patients presenting with chronic mesh infection and/or enteric fistulas were enrolled in this prospective study. The active infection group (AI) was compared to a cohort of 38 patients submitted to clean ventral hernia repairs (CC). The inclusion criteria in the AI group were the presence of active chronic mesh infection (non-healing sinus, exposed mesh, or mesh-related enteric fistulas) resulting from a previous repair, or the presence of an enteric/enteroatmospheric fistula, with or without an associated abdominal wall defect. The patients invited to participate as controls had a primary or recurrent ventral hernia without previous history of infection and were eligible for clean operations. The operations in the AI group were classified as Class IV (dirty-infected), according to the CDC Wound Classifications, as adopted by the European registry for abdominal wall hernias.
The exclusion criteria were giant ventral hernias, patients on immunosuppressive or corticosteroid therapy, patients with portal hypertension, Crohn's disease, acute postoperative mesh infection, chronic infections following inguinal hernia repair, and emergency operations.
Demographic data included age, gender, American Society of Anesthesiologists (ASA) score, body mass index (BMI), comorbidities, smoking status, cancer history, and the number of previous abdominal operations. Perioperative details included the list of associated procedures, the defect width, the extension of the pre-aponeurotic dissection, operative time, and anesthesia time. Further analysis in the AI group included the clinical presentation, the onset of symptoms, the type and position of the infected mesh, the possible causes for mesh infection, and the microbiology of mesh explants.
Patients were followed and operated at the Abdominal Wall and Hernia Repair Unit at the Hospital das Clínicas, University of São Paulo, Brazil. Six surgeons of the team conducted the operations in both groups. The local ethics committee approved the study. Informed consent was obtained from all individual participants. The study was registered at the national registry, Plataforma Brasil (https://plataformabrasil.saude.gov.br/login.jsf), CAAE 52383615.0.0000.0068, and Identifier 1.412.367.
All the mesh samples used were provided by the manufacturer (FEG Textiltechnik, Aachen, Germany) through their local dealer (BMR Medical, www.bmrmedical.com.br), at no cost. None of the authors or our institution received any financial support to undertake the study.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 86 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Study group: patients with the presence of an active chronic mesh infection (non-healing sinus, exposed mesh, or mesh-related enteric fistulas) resulting from a previous repair, or the presence of an enteric/enteroatmospheric fistula, with or without an associated abdominal wall defect
- •Control group: patients with a primary or recurrent ventral hernia without previous history of infection and eligible for clean operations
Exclusion Criteria
- •giant ventral hernias with a volume ratio higher than 25% and loss of domicile
- •patients on immunosuppressive therapy or using corticosteroids
- •patients with portal hypertension
- •patients with Chron´s disease
- •acute postoperative mesh infection
- •chronic mesh infections following inguinal hernia repair
- •emergency operations.
Outcomes
Primary Outcomes
Surgical site infection
Time Frame: 30 days
as an infection occurring where the surgery took place and was further defined as superficial, deep, and organ space
Surgical site occurence
Time Frame: 30 days
any surgical infection, wound breakdown, soft tissue ischemia, seroma, and hematoma formation
Secondary Outcomes
- Hernia recurrence(6 and 36 months)
- Infection recurrence(6 and 36 months)
Investigators
Claudio Birolini
MD, phD. Director of General Surgery of the Third Division of Clinical Surgery of the Department of Surgery, Head of the Hernias and Abdominal Wall Group
University of Sao Paulo General Hospital
