Synthetic Mesh Explant Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01880021

Enrollment

111

Registered

2013-06-18

Start date

2008-03-31

Completion date

2016-09-30

Last updated

2016-09-23

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

Conditions

Herniorrhaphy, Histology, Humans, Materials Testing, Polypropylene, Polytetrafluoroethylene

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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 corticosteroid/immunosuppression therapy	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.
Number of subjects with history of chemotherapy	Within 2 weeks	Identify possible clinical characteristics which affect mesh degradation.

Countries

United States

Outcome results