Skip to main content
OpenTrials
Completed

NCT Number: NCT01880021

Synthetic Mesh Explant Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Herniorrhaphy Histology Humans Materials Testing Polypropylene Polytetrafluoroethylene

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fibrosis level of explanted mesh

    Time frame: 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 outcomes

  1. Tensile strength of explanted mesh

    Time frame: Within 2 weeks

    Each specimen will be tested for tensile strength to determine force versus displacement.

  2. Collagen protein levels of explanted mesh.

    Time frame: 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.

  3. Number of subjects with history of radiation to abdomen/pelvis

    Time frame: Within 2 weeks

    Identify possible clinical characteristics which affect mesh degradation.

  4. Number of subjects with history of chemotherapy

    Time frame: Within 2 weeks

    Identify possible clinical characteristics which affect mesh degradation.

  5. Number of subjects with corticosteroid/immunosuppression therapy

    Time frame: Within 2 weeks

    Identify possible clinical characteristics which affect mesh degradation.

  6. Number of subjects with history of tobacco use

    Time frame: Within 2 weeks

    Identify possible clinical characteristics which affect mesh degradation.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Jun 18, 2013
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.