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Analysis and Characterization of Biologic Implants

NCT01060046 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 241

Last updated 2018-05-14

No results posted yet for this study

Summary

The purpose of this study is to investigate what happens to biologic mesh in the body over time on a molecular level. To date, it is not known what agents, enzymes, or proteins are interacting at the implantation site that contributes to mesh remodeling and/or degradation. Investigators on this project will identify patients with previously placed mesh who are needing reoperation on the same site and take a biopsy of the mesh during the normal course of surgery. Basic data surrounding the surgical procedure will be collected. The mesh samples will be analyzed for enzymes and proteins and examined histologically for processes that signify remodeling and/or degradation. Control patients will undergo biopsy of abdominal fascia at laparoscopic trocar sites in a manner that will not affect the outcome(s) of their procedure or other risk to the incision site.

Conditions

  • Ventral Hernia
  • Post-mastectomy Breast Reconstruction

Sponsors & Collaborators

  • Musculoskeletal Transplant Foundation

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Brent D Matthews, MD · Washington University School of Medicine

  • Corey Deeken, PhD · Washington University School of Medicine

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01060046 on ClinicalTrials.gov