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Synthetic Mesh Explant Study

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ClinicalTrials.gov Identifier: NCT01880021
Recruitment Status : Completed
First Posted : June 18, 2013
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Herniorrhaphy Humans Polypropylene Polytetrafluoroethylene Histology Materials Testing

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Study Type : Observational
Actual Enrollment : 111 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Characterization of Explanted Hernia Meshes From Human Subjects: A Prospective Study
Study Start Date : March 2008
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from study investigators' patient population.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880021


Locations
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United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Michael Brunt, MD Washington University School of Medicine

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01880021     History of Changes
Other Study ID Numbers: 2010-12735
First Posted: June 18, 2013    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016