The Use of Synthetic Mesh in Contaminated and Infected Abdominal Wall Repairs. A Long-term Prospective Clinical Trial

October 9, 2018 updated by: Claudio Birolini, University of Sao Paulo General Hospital

The Use of Synthetic Mesh in Contaminated and Infected Abdominal Wall Repairs: Challenging the Dogma of an Absolute Contra-indication. A Long-term Prospective Clinical Trial

Background: Abdominal wall reconstruction in patients presenting with enteric fistulas and mesh infection is challenging. There is a consensus that synthetic mesh must be avoided in infected operations. The alternatives to using synthetic mesh, such as component separation techniques and biologic mesh, present disappointing results with expressive wound infection and hernia recurrence rates.

Methods: A prospective clinical trial designed to evaluate the short and the long-term outcomes of patients submitted to elective abdominal wall repair with synthetic mesh in the dirty-infected setting, and compared to a cohort of patients submitted to clean ventral hernia repairs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We designed a prospective study, evaluating the short and the long-term outcomes of the surgical treatment of 40 consecutive patients presenting with an infected abdominal wall, compared to a cohort of 40 patients submitted to clean ventral hernia repairs. Patients were admitted between January 2012 and February 2015, and operated at the Hospital das Clinicas of the University of São Paulo School of Medicine, in Brazil. All patients included in the study group carried an active chronic mesh infection (mesh sinus, exposed mesh or mesh related enteric fistulas) resulting from a previous hernia repair, with or without an associated recurrent ventral hernia. All the operations required in this group were classified as Class IV (dirty-infected), accordingly to the CDC Wound Classifications, as adopted by the European registry for abdominal wall hernias. The only inclusion criterion was the presence of an active chronic mesh infection. The infected abdominal wall (IM) group and the outcomes of the treatment were compared to a clean-control (CC) group of patients who underwent clean abdominal wall reconstructions, originally belonging to a prospective study of the tensiometry of the abdominal wall, and operated during the same period and in the same conditions. The exclusion criteria were: giant ventral hernias with a volume ratio higher than 25%, patients on immunosuppressive therapy or using corticosteroids, patients with hepatic cirrhosis and portal hypertension, Chron´s disease, acute postoperative mesh infection, chronic mesh infections following inguinal hernia repair and emergency operations.The data assessed included gender, age, body mass index (BMI), American Society of Anesthesiologists (ASA) score, comorbidities, smoking status, cancer history, the number of previous abdominal operations, the number of prior hernia operations, the presence of a recurrent incisional hernia and/or enteric fistula and the presentation of the mesh infection. Perioperative data included operative time, anesthesia time, associated procedures, the defect characteristics and the extension of the pre-aponeurotic dissection. Further analysis in the infected mesh (IM) group included the type and position of the infected mesh, the causes for the mesh infection and the microbiology of mesh explants. Patients were followed and operated at the Abdominal Wall and Hernia Repair Unit of the General Surgery and Trauma Discipline, and five surgeons of the team conducted the operations in both groups. Informed consents were presented to the patients in the IM group upon admission. Patients in the CC group signed informed consents to participate the study, during their post-operative follow-up visits.

Surgical procedure The operations were performed through the previous surgical incision. Patients in the IM group had the infected mesh removed completely together with all the sutures, tacks or other foreign material. The surrounding fibrotic tissue and the existing sinus tracts were resected to perform a complete toilet of the abdominal wall. The abdominal cavity was entered in most of the patients, and associated or incidental procedures were made as required. After the removal of the infected mesh, or at the end of the abdominal cavity workup, all the surgical drapes, instruments and gloves were replaced. The size of the defect and the extension of the anterior abdominal wall dissection were estimated. The reconstruction of the midline was done as anatomically as possible, by repositioning of the muscles and primary closure of the aponeurosis. We did not use component separation techniques or transverse abdominal releases in any case. In some patients, a bilateral relaxing incision along the anterior rectus sheath was required to allow the re-approximation of the muscles in the midline. In all patients, a heavyweight macroporous (pore size > 75µm) monofilament polypropylene mesh (Intracorp®, Venkuri, www.venkuri.com.br) was used in the onlay position, to reinforce the repair. The mesh was fixed with multiple absorbable Vicryl® sutures, placed over the borders of the mesh, in the midline and along the relaxing incisions. The remaining dead space between the mesh and the underlying tissue was cleared entirely with interrupted sutures. The operative field was irrigated with 0,9% saline, and the subcutaneous was drained with suction drains. The scars and the exceeding skin flaps were resected. We did not use irrigation with antibiotics solution. The subcutaneous tissue and the skin were closed with interrupted sutures. Fluids and samples of the explanted mesh were sent to cultures and microbiological analysis. The same technique of repair was used in the CC group. The size of the defect was measured, and the extension of the anterior abdominal wall dissection was estimated. A bilateral relaxing incision along the anterior rectus sheath was used routinely in this group, to allow a tensionless closure of the midline.

Outcomes parameters The primary outcomes variables were the presence of any surgical site occurrences (SSO) or surgical site infection (SSI) during the first 30 days after the operation, and the development of hernia recurrence or the recurrence of mesh infection during a 36-month follow-up period. Suspected recurrences of a hernia or infection were determined by physical examination and CT scan imaging. Non-surgical complications, other operations, and deaths were registered during the follow-up period.

Statistical Analysis The chi-square test was conducted to verify the association between categorical variables in contingency tables and the Fisher exact test was adopted in 2x2 tables whenever at least one expected frequency was less than 5. The U-test was used for verifying the association between continuous data and group with two categories, and when normal distribution was observed the Student t-test was performed. The 5% level of significance was considered for all statistical tests. Statistical computer Stata software version 10.0 (StataCorp, College Station, TX) was used for conducting all statistical analysis.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

"Inclusion Criterion"

- the presence of an active chronic mesh infection

"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 hepatic cirrhosis and portal hypertension
  • Chron´s disease
  • acute postoperative mesh infection
  • chronic mesh infections following inguinal hernia repair
  • emergency operations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Infected abdominal wall group
A cohort of 40 patients carrying an active chronic mesh infection (mesh sinus, exposed mesh or mesh related enteric fistulas) resulting from a previous hernia repair, with or without an associated recurrent ventral hernia, and submitted to abdominal wall reconstruction with synthetic mesh.
Procedure: Abdominal wall reconstruction
The repair of abdominal wall defects with polypropylene mesh
Other Names:
  • Ventral hernia repair
ACTIVE_COMPARATOR: Clean control group
A cohort of 40 patients with ventral hernias, and submitted to clean ventral hernia repair with synthetic mesh.
Procedure: Abdominal wall reconstruction
The repair of abdominal wall defects with polypropylene mesh
Other Names:
  • Ventral hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical site occurrence
Time Frame: 30 days
any surgical infection, wound breakdown, soft tissue ischemia, seroma and hematoma formation
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Site infection
Time Frame: 30 days
an infection occurring in the part of the body where the surgery took place and further defined as superficial, deep, and organ space
30 days
Surgical site occurrence requiring procedural intervention
Time Frame: 30 days
any wound event requiring opening of the wound, wound debridement, suture excision, percutaneous drainage, hematoma evacuation, or mesh removal
30 days
Ventral hernia recurrence
Time Frame: 36 months
a recurrence of ventral hernia
36 months
Mesh infection recurrence
Time Frame: 36 months
a recurrence of mesh infection
36 months

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Claudio Birolini, MD, Hospital das Clinicas da FMUSP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2012

Primary Completion (ACTUAL)

February 28, 2015

Study Completion (ACTUAL)

February 28, 2018

Study Registration Dates

First Submitted

October 8, 2018

First Submitted That Met QC Criteria

October 9, 2018

First Posted (ACTUAL)

October 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 10, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPM - Prospective

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Brief records and pictures, both of the operations and follow up data, are available.

IPD Sharing Time Frame

From march 2018, 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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