Abdominal Wall Reconstruction With PVDF Mesh in the Setting of Active Infection

Complex Abdominal Wall Reconstruction With Polyvinylidene (PVDF) Mesh in the Setting of Active Infection: a Prospective Case-control Series.

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Wall Defect; Infection; Abdominal Wall Hernia; Abdominal Wall Fistula; Abdominal Wall Infection
• Intervention / Treatment: Procedure: Abdominal wall reconstruction

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.

The primary outcomes were the presence of any surgical site occurrences (SSO) or surgical site infection (SSI) during the first 30 days after the operation. The secondary outcomes included developing hernia recurrence or the recurrence of mesh infection during a 6-month follow-up period. An SSI was defined as an infection occurring where the surgery took place and was further defined as superficial, deep, and organ space. An SSO was described as any surgical infection, wound breakdown, soft tissue ischemia, seroma, and hematoma formation. A surgical site occurrence requiring procedural intervention (SSOPI) was described as any wound event requiring the opening of the wound, wound debridement, suture excision, percutaneous drainage, hematoma evacuation, or mesh removal [14]. The Clavien-Dindo classification [15] (Table 2) was applied to all surgical complications. Suspected recurrences of a hernia or infection were determined by physical examination and CT scan imaging. Non-surgical complications, other operations, and deaths were recorded during the follow-up period.

The statistical analysis was performed using the computer software Stata: version 16.0 (Stata Corp. 2019. Stata: Release 16. Statistical Software. College Station, TX: Stata Corp LLC). The frequency distribution was used by means to describe categorical variables (number of cases and relative percentage) and for continuous variables, measures of central tendency (median and mean) and variability (range and standard deviation). The nonparametric Mann-Whitney U test was applied for the statistical evaluation of the association between groups and continuous variables. The Student t-test was adopted when data normality was identified. Shapiro-Wilk test was applied to verify the normality of data. The association between categorical variables in contingency tables was analyzed using the frequency Chi-square test and the Fisher exact test adopted in 2x2 tables whenever at least one expected frequency was less than five. The 5% significance level was considered for all statistical tests.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-000
    • Hospital das Clinicas da FMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 86 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Active infection group; A cohort of 38 patients carrying an active infection (mesh sinus, exposed mesh or enteric fistulas) resulting from a previous hernia repair, with or without an associated recurrent ventral hernia, and submitted to abdominal wall reconstruction with PVDF mesh.	Procedure: Abdominal wall reconstruction; The repair of abdominal wall defects with polyvinylidene (PVDF) mesh; Other Names: Ventral hernia repair
ACTIVE_COMPARATOR: Clean control group; A cohort of 38 patients with ventral hernias, and submitted to clean ventral hernia repair with PVDF mesh.	Procedure: Abdominal wall reconstruction; The repair of abdominal wall defects with polyvinylidene (PVDF) mesh; Other Names: Ventral hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site occurence	any surgical infection, wound breakdown, soft tissue ischemia, seroma, and hematoma formation	30 days
Surgical site infection	as an infection occurring where the surgery took place and was further defined as superficial, deep, and organ space	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hernia recurrence	the recurrence of an incisional hernia	6 and 36 months
Infection recurrence	the recurrence of a chronic infection, or mesh related infection	6 and 36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiology of mesh infection	the study of the microorganisms causing chronic infection	30 days

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Claudio Birolini, MD, Hospital das Clinicas da FMUSP

Publications and helpful links

General Publications

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
• Birolini C, de Miranda JS, Tanaka EY, Utiyama EM, Rasslan S, Birolini D. The use of synthetic mesh in contaminated and infected abdominal wall repairs: challenging the dogma-A long-term prospective clinical trial. Hernia. 2020 Apr;24(2):307-323. doi: 10.1007/s10029-019-02035-2. Epub 2019 Sep 6.
• Klinge U, Klosterhalfen B, Ottinger AP, Junge K, Schumpelick V. PVDF as a new polymer for the construction of surgical meshes. Biomaterials. 2002 Aug;23(16):3487-93. doi: 10.1016/s0142-9612(02)00070-4.
• Garner JS. CDC guideline for prevention of surgical wound infections, 1985. Supersedes guideline for prevention of surgical wound infections published in 1982. (Originally published in November 1985). Revised. Infect Control. 1986 Mar;7(3):193-200. doi: 10.1017/s0195941700064080. No abstract available.
• Haskins IN, Horne CM, Krpata DM, Prabhu AS, Tastaldi L, Perez AJ, Rosenblatt S, Poulose BK, Rosen MJ. A call for standardization of wound events reporting following ventral hernia repair. Hernia. 2018 Oct;22(5):729-736. doi: 10.1007/s10029-018-1748-6. Epub 2018 Feb 10.
• Hodgkinson JD, Maeda Y, Leo CA, Warusavitarne J, Vaizey CJ. Complex abdominal wall reconstruction in the setting of active infection and contamination: a systematic review of hernia and fistula recurrence rates. Colorectal Dis. 2017 Apr;19(4):319-330. doi: 10.1111/codi.13609.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2016
• Primary Completion (ACTUAL): January 1, 2021
• Study Completion (ACTUAL): September 1, 2021

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (ACTUAL): September 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 6, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: ventral hernia; synthetic mesh; abdominal wall reconstruction; mesh infection; enteric fistula; complex hernia; polyvinylidene mesh; DynaMesh
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Infections; Communicable Diseases; Hernia; Fistula; Hernia, Ventral; Hernia, Abdominal; Internal Hernia
• Other Study ID Numbers: PVDF mesh

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient records and pictures, both of the operations and follow up data, are available.
• IPD Sharing Time Frame: From september 2021, available for 1 year
• IPD Sharing Access Criteria: Available data to be shared with researchers interested in abdominal wall reconstruction
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No