Characterization of Explanted Hernia Meshes From Human Subjects: A Multi-Center, Prospective Study
Study Details
Study Description
Brief Summary
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.
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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 Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults (persons 18 and older)
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Previous placement of hernia mesh material
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Current need for excision of previous mesh placement or current need for intra-abdominal surgical procedure
Exclusion Criteria:
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No retained mesh prosthetic
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Non surgical candidate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Missouri Hospital and Clinics | Columbia | Missouri | United States | 65212 |
Sponsors and Collaborators
- University of Missouri-Columbia
- Mayo Clinic
- Washington University School of Medicine
- University Hospitals Cleveland Medical Center
Investigators
- Principal Investigator: Bruce Ramshaw, MD, University of Missouri-Columbia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MO-5006-1076737