Synthetic Mesh Explant Study

Completed

• Conditions: Herniorrhaphy; Polytetrafluoroethylene; Polypropylene; Materials Testing; Humans; Histology

• Registration Number: NCT01880021
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of this study is to determine whether synthetic hernia mesh materials undergo physical and/or chemical changes while in the body.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2013-05-31
• Study First Submitted QC: 2013-06-13
• Study First Posted: 2013-06-18
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-21
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fibrosis level of explanted mesh	Within 2 weeks	Each specimen will be graded and given fibrosis score of 0 - 4 to establish the degree of inflammation/foreign body reaction that occurred while mesh was in vivo.

Secondary Outcome Measures

Name	Time	Method
Number of subjects with corticosteroid/immunosuppression therapy	Within 2 weeks	Identify possible clinical characteristics which affect mesh degradation.
Tensile strength of explanted mesh	Within 2 weeks	Each specimen will be tested for tensile strength to determine force versus displacement.
Number of subjects with history of chemotherapy	Within 2 weeks	Identify possible clinical characteristics which affect mesh degradation.
Collagen protein levels of explanted mesh.	Within 2 weeks	The total amount of collagen and non-collagenous proteins in cultured cell layers and tissue sections by differential staining with two dyes, sirius red and fast green. Sirius Red binds to all types of collagen, whereas fast green stains non-collagenous proteins.
Number of subjects with history of radiation to abdomen/pelvis	Within 2 weeks	Identify possible clinical characteristics which affect mesh degradation.
Number of subjects with history of tobacco use	Within 2 weeks	Identify possible clinical characteristics which affect mesh degradation.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States