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

Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00484887
• Other study ID #: MO-5006-1076737
• Status: Terminated
• Phase: N/A
• First received: June 7, 2007
• Last updated: August 5, 2016
• Start date: April 2007
• Est. completion date: February 2012

Study information

• Verified date: May 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 272
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Pathological Conditions, Signs and Symptoms
• Signs and Symptoms

Locations

Country	Name	City	State
United States	University of Missouri Hospital and Clinics	Columbia	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
University of Missouri-Columbia	Mayo Clinic, University Hospital Case Medical Center, Washington University School of Medicine

Country where clinical trial is conducted

United States,