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

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ClinicalTrials.gov Identifier: NCT03702153
Recruitment Status : Completed
First Posted : October 10, 2018
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Claudio Birolini, University of Sao Paulo General Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Abdominal Wall Defect Abdominal Wall Infection Abdominal Wall Fistula Infection Procedure: Abdominal wall reconstruction Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A study group submitted to abdominal wall repair with synthetic mesh in the contaminated/infected setting compared to a control group submitted to abdominal wall repair with synthetic mesh in the clean setting.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 1, 2012
Actual Primary Completion Date : February 28, 2015
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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 Name: 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 Name: Ventral hernia repair




Primary Outcome Measures :
  1. Surgical site occurrence [ Time Frame: 30 days ]
    any surgical infection, wound breakdown, soft tissue ischemia, seroma and hematoma formation


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Ventral hernia recurrence [ Time Frame: 36 months ]
    a recurrence of ventral hernia

  4. Mesh infection recurrence [ Time Frame: 36 months ]
    a recurrence of mesh infection


Other Outcome Measures:
  1. Microbiology of mesh infection [ Time Frame: 30 days ]
    a study of the microorganisms causing chronic mesh infection



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

"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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702153


Locations
Brazil
Hospital das Clinicas da FMUSP
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Claudio Birolini, MD Hospital das Clínicas da FMUSP

Additional Information:
Publications:

Responsible Party: Claudio Birolini, MD, PhD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03702153     History of Changes
Other Study ID Numbers: PPM - Prospective
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Brief records and pictures, both of the operations and follow up data, are available.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: From march 2018, available for 1 year
Access Criteria: Available data to be shared with researchers interested in abdominal wall reconstruction
URL: https://vimeo.com/90585364

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Claudio Birolini, University of Sao Paulo General Hospital:
ventral hernia
mesh infection
enteric fistula
polypropylene mesh
synthetic mesh
abdominal wall reconstruction
complex hernia

Additional relevant MeSH terms:
Infection
Communicable Diseases
Fistula
Pathological Conditions, Anatomical