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

Primary Purpose

Abdominal Wall Defect, Abdominal Wall Hernia, Abdominal Wall Infection

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Abdominal wall reconstruction
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Wall Defect focused on measuring ventral hernia, mesh infection, enteric fistula, polyvinylidene mesh, synthetic mesh, abdominal wall reconstruction, complex hernia, DynaMesh

Eligibility Criteria

20 Years - 86 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital das Clinicas da FMUSP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active infection group

Clean control group

Arm Description

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.

A cohort of 38 patients with ventral hernias, and submitted to clean ventral hernia repair with PVDF mesh.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hernia recurrence
the recurrence of an incisional hernia
Infection recurrence
the recurrence of a chronic infection, or mesh related infection

Full Information

First Posted
September 20, 2021
Last Updated
September 28, 2021
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05061264
Brief Title
Abdominal Wall Reconstruction With PVDF Mesh in the Setting of Active Infection
Official Title
Complex Abdominal Wall Reconstruction With Polyvinylidene (PVDF) Mesh in the Setting of Active Infection: a Prospective Case-control Series.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
January 2021 (Actual)
Study Completion Date
September 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Wall Defect, Abdominal Wall Hernia, Abdominal Wall Infection, Abdominal Wall Fistula, Infection
Keywords
ventral hernia, mesh infection, enteric fistula, polyvinylidene mesh, synthetic mesh, abdominal wall reconstruction, complex hernia, DynaMesh

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A study group submitted to abdominal wall repair with PVDF mesh in the infected setting compared to a control group submitted to abdominal wall repair with PVDF mesh in the clean setting.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active infection group
Arm Type
Experimental
Arm Description
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.
Arm Title
Clean control group
Arm Type
Active Comparator
Arm Description
A cohort of 38 patients with ventral hernias, and submitted to clean ventral hernia repair with PVDF mesh.
Intervention Type
Procedure
Intervention Name(s)
Abdominal wall reconstruction
Other Intervention Name(s)
Ventral hernia repair
Intervention Description
The repair of abdominal wall defects with polyvinylidene (PVDF) mesh
Primary Outcome Measure Information:
Title
Surgical site occurence
Description
any surgical infection, wound breakdown, soft tissue ischemia, seroma, and hematoma formation
Time Frame
30 days
Title
Surgical site infection
Description
as an infection occurring where the surgery took place and was further defined as superficial, deep, and organ space
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Hernia recurrence
Description
the recurrence of an incisional hernia
Time Frame
6 and 36 months
Title
Infection recurrence
Description
the recurrence of a chronic infection, or mesh related infection
Time Frame
6 and 36 months
Other Pre-specified Outcome Measures:
Title
Microbiology of mesh infection
Description
the study of the microorganisms causing chronic infection
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Birolini, MD
Organizational Affiliation
Hospital das Clinicas da FMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas da FMUSP
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
31493051
Citation
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.
Results Reference
background
PubMed Identifier
12099293
Citation
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.
Results Reference
background
PubMed Identifier
3633903
Citation
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.
Results Reference
background
PubMed Identifier
29429064
Citation
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.
Results Reference
background
PubMed Identifier
15273542
Citation
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.
Results Reference
background
PubMed Identifier
28102927
Citation
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.
Results Reference
result

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

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