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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2009 by University of Missouri-Columbia
Sponsor:
Collaborators:
Mayo Clinic
Washington University School of Medicine
University Hospitals of Cleveland
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00484887
First received: June 7, 2007
Last updated: August 17, 2009
Last verified: August 2009
  Purpose

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.


Condition
Pathological Conditions, Signs and Symptoms
Hernia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Characterization of Explanted Hernia Meshes From Human Subjects: A Multi-Center, Prospective Study

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Biospecimen Retention:   Samples Without DNA

Explanted mesh from surgical procedures.


Estimated Enrollment: 1000
Study Start Date: April 2007
Estimated Study Completion Date: December 2017
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Surgical patients at the University of Missouri Healthcare system.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484887

Contacts
Contact: Sharon L. Bachman, MD 573-884-4003 bachmans@missouri.edu
Contact: Bruce Ramshaw, MD 573-884-5670 ramshawb@health.missouri.edu

Locations
United States, Missouri
University of Missouri Hospital and Clinics Recruiting
Columbia, Missouri, United States, 65212
Contact: Sharon L. Bachman, MD    573-884-4003    bachmans@missouri.edu   
Contact: Bruce Ramshaw, MD    573-884-5670    ramshawb@health.missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
Mayo Clinic
Washington University School of Medicine
University Hospitals of Cleveland
Investigators
Principal Investigator: Bruce Ramshaw, MD University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Bruce Ramshaw, MD, University of Missouri Healthcare
ClinicalTrials.gov Identifier: NCT00484887     History of Changes
Other Study ID Numbers: MO-5006-1076737
Study First Received: June 7, 2007
Last Updated: August 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
Hernia mesh
Implanted mesh material
Explanted mesh material

Additional relevant MeSH terms:
Hernia
Signs and Symptoms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 18, 2014