Skip to content

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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00484887
Enrollment
272
Registered
2007-06-11
Start date
2007-04-30
Completion date
2012-02-29
Last updated
2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Pathological Conditions, Signs and Symptoms

Keywords

Hernia mesh, Implanted mesh material, Explanted mesh material

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.

Interventions

None listed

Sponsors

Mayo Clinic
CollaboratorOTHER
Washington University School of Medicine
CollaboratorOTHER
University Hospitals Cleveland Medical Center
CollaboratorOTHER
University of Missouri-Columbia
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026