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

NCT03702153 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-10-10

No results posted yet for this study

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.

Conditions

  • Abdominal Wall Defect
  • Abdominal Wall Infection
  • Abdominal Wall Fistula
  • Infection

Interventions

PROCEDURE

Abdominal wall reconstruction

The repair of abdominal wall defects with polypropylene mesh

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Claudio Birolini, MD · Hospital das Clínicas da FMUSP

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-01
Primary Completion
2015-02-28
Completion
2018-02-28

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03702153 on ClinicalTrials.gov