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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

272 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Synthetic Mesh Explant Study

NCT01880021

Polypropylene Polytetrafluoroethylene Histology +3 more

COMPLETED

Incisional Hernia Outcomes Study Using Parietex Composite Mesh

NCT00459602

Incisional Hernia

TERMINATED

Long Term Outcomes Following Hernia Repair With Mesh

NCT04578340

Abdominal Hernia

RECRUITING

Complex Abdominal Wall Reconstruction Using Biologic Mesh

NCT04780048

Hernia

UNKNOWN

Comparison of Sample Characteristics Between Subjects Who Received Strattice Mesh for Abdominal Wall Reconstruction

NCT04534920

Hernia

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pathological Conditions, Signs and Symptoms Hernia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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