View Clinical Trial (Medical Research Study)
Characterization of Explanted Hernia Meshes From Human Subjects: A Multi-Center, Prospective Study
| City: |
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Columbia |
| State: |
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Missouri |
| Zip Code: |
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65212 |
| Conditions: |
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Pathological Conditions, Signs and Symptoms - Hernia |
| Purpose: |
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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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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00484887 |
| Primary Contact: |
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Principal Investigator
Bruce Ramshaw, MD
University of Missouri-Columbia
Sharon L. Bachman, MD
Phone: 573-884-4003
Email: bachmans@missouri.edu
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| Backup Contact: |
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Email: ramshawb@health.missouri.edu
Bruce Ramshaw, MD
Phone: 573-884-5670
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| Location Contact: |
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Columbia, Missouri 65212
United States
Sharon L. Bachman, MD
Phone: 573-884-4003
Email: bachmans@missouri.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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