Characterization of Explanted Hernia Meshes From Human Subjects: A Multi-Center, Prospective Study

This study will collect a large amount of hernia mesh explants and study the changes that occur in the materials in vivo to use the information to help design new mesh made from novel materials. We will have evidence that our current options are not only inadequate but can lead to complications. One of our main goals is to convince our colleagues to change their surgical practice by publishing and educating them with this data.

Study Overview

• Status: Terminated
• Conditions: Hernia; Pathological Conditions, Signs and Symptoms

Detailed Description

This study will collect a large amount of hernia mesh explants and study the changes that occur in the materials in vivo to use the information to help design new mesh made from novel materials. We will have evidence that our current options are not only inadequate but can lead to complications. One of our main goals is to convince our colleagues to change their surgical practice by publishing and educating them with this data. The objectives of this study are to establish the largest collection of explanted mesh materials in the country; demonstrate by common testing utilized by materials engineers, that in vivo exposure of mesh to the oxidants produced by phagocytosis may lead to chain scission, production of free radicals, and overall degradation of the material both physically and chemically; test mesh materials for a decrease in compliance, which would account for a tendency of mesh to stiffen while in the body reducing abdominal mobility and leading to chronic pain; characterize the histologic reaction of tissues to mesh; and utilize de-identified patient demographics to identify possible clinical characteristics which affect mesh degradation.

• Study Type: Observational
• Enrollment (Actual): 272

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Surgical patients at the University of Missouri Healthcare system.

Description

Inclusion Criteria:

• Adults (persons 18 and older)
• Previous placement of hernia mesh material
• Current need for excision of previous mesh placement or current need for intra-abdominal surgical procedure

Exclusion Criteria:

• No retained mesh prosthetic
• Non surgical candidate

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Collaborators: Mayo Clinic; Washington University School of Medicine; University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: Bruce Ramshaw, MD, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: June 7, 2007
• First Submitted That Met QC Criteria: June 7, 2007
• First Posted (Estimate): June 11, 2007

Study Record Updates

• Last Update Posted (Estimate): August 8, 2016
• Last Update Submitted That Met QC Criteria: August 5, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Hernia mesh; Implanted mesh material; Explanted mesh material
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: MO-5006-1076737

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO