Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484887
Status:
TERMINATED
Last Update Posted:
2016-08-08
First Post:
2007-06-07
Brief Title:
Characterization of Explanted Hernia Meshes From Human Subjects A Multi-Center Prospective Study
Sponsor:
University of Missouri-Columbia
Organization:
University of Missouri-Columbia
Study Overview
Official Title:
Characterization of Explanted Hernia Meshes From Human Subjects A Multi-Center Prospective Study
Status:
TERMINATED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None