Synthetic Mesh Explant Study

Humans Clinical Trial

Official title:

Characterization of Explanted Hernia Meshes From Human Subjects: A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880021
• Other study ID #: 2010-12735
• Status: Completed
• Phase: N/A
• First received: May 31, 2013
• Last updated: September 21, 2016
• Start date: March 2008
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Age = 18 yrs

• Previous placement of hernia mesh material

• Current need for excision of previous mesh placement or Current need for intra-abdominal surgical procedure

Exclusion criteria:

• Age < 18 yrs

• No retained mesh prosthetic.

• Non surgical candidate

• Prisoner

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Herniorrhaphy
• Histology
• Humans
• Materials Testing
• Polypropylene
• Polytetrafluoroethylene

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibrosis level of explanted mesh	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.	Within 2 weeks	No
Secondary	Tensile strength of explanted mesh	Each specimen will be tested for tensile strength to determine force versus displacement.	Within 2 weeks	No
Secondary	Collagen protein levels of explanted mesh.	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.	Within 2 weeks	No
Secondary	Number of subjects with history of radiation to abdomen/pelvis	Identify possible clinical characteristics which affect mesh degradation.	Within 2 weeks	No
Secondary	Number of subjects with history of chemotherapy	Identify possible clinical characteristics which affect mesh degradation.	Within 2 weeks	No
Secondary	Number of subjects with corticosteroid/immunosuppression therapy	Identify possible clinical characteristics which affect mesh degradation.	Within 2 weeks	No
Secondary	Number of subjects with history of tobacco use	Identify possible clinical characteristics which affect mesh degradation.	Within 2 weeks	No