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

Terminated

• Conditions: Hernia; Pathological Conditions, Signs and Symptoms

• Registration Number: NCT00484887
• Lead Sponsor: University of Missouri-Columbia

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 Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-06-07
• Study First Submitted QC: 2007-06-07
• Study First Posted: 2007-06-11
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2016-05
• Last Update Submitted: 2016-08-05
• Last Update Posted: 2016-08-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 272

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of Missouri Hospital and Clinics; 🇺🇸 Columbia, Missouri, United States