Synthetic Mesh Explant Study

September 21, 2016 updated by: Washington University School of Medicine

Characterization of Explanted Hernia Meshes From Human Subjects: A Prospective Study

The purpose of this study is to determine whether synthetic hernia mesh materials undergo physical and/or chemical changes while in the body.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

111

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

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be recruited from study investigators' patient population.

Description

Inclusion criteria:

  • Age ≥ 18 yrs
  • Previous placement of hernia mesh material
  • Current need for excision of previous mesh placement or Current need for intra-abdominal surgical procedure

Exclusion criteria:

  • Age < 18 yrs
  • No retained mesh prosthetic.
  • Non surgical candidate
  • Prisoner

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibrosis level of explanted mesh
Time Frame: Within 2 weeks
Each specimen will be graded and given fibrosis score of 0 - 4 to establish the degree of inflammation/foreign body reaction that occurred while mesh was in vivo.
Within 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tensile strength of explanted mesh
Time Frame: Within 2 weeks
Each specimen will be tested for tensile strength to determine force versus displacement.
Within 2 weeks
Collagen protein levels of explanted mesh.
Time Frame: Within 2 weeks
The total amount of collagen and non-collagenous proteins in cultured cell layers and tissue sections by differential staining with two dyes, sirius red and fast green. Sirius Red binds to all types of collagen, whereas fast green stains non-collagenous proteins.
Within 2 weeks
Number of subjects with history of radiation to abdomen/pelvis
Time Frame: Within 2 weeks
Identify possible clinical characteristics which affect mesh degradation.
Within 2 weeks
Number of subjects with history of chemotherapy
Time Frame: Within 2 weeks
Identify possible clinical characteristics which affect mesh degradation.
Within 2 weeks
Number of subjects with corticosteroid/immunosuppression therapy
Time Frame: Within 2 weeks
Identify possible clinical characteristics which affect mesh degradation.
Within 2 weeks
Number of subjects with history of tobacco use
Time Frame: Within 2 weeks
Identify possible clinical characteristics which affect mesh degradation.
Within 2 weeks

Collaborators and Investigators

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

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Michael Brunt, MD, Washington University School of Medicine

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

March 1, 2008

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 31, 2013

First Submitted That Met QC Criteria

June 13, 2013

First Posted (Estimate)

June 18, 2013

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 21, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2010-12735

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.

Subscribe