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Analysis and Characterization of Biologic Implants

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Musculoskeletal Transplant Foundation
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01060046
First received: January 28, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition
Ventral Hernia
Post-mastectomy Breast Reconstruction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Analysis and Characterization of in Vivo Tissue Remodeling in Routine Biologic Mesh Explants From Patients Undergoing Reoperation for Recurrent Hernia or Revision of a Prior Surgical Site

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Biospecimen Retention:   Samples Without DNA

Biopsy samples of previously implanted biologic meshes, biopsy samples of native abdominal wall fascia


Estimated Enrollment: 200
Study Start Date: August 2007
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with previously implanted biologic mesh
All patients undergoing a repeat operation to repair a recurrent hernia or to revise a surgical site which has been previously repaired using a biologic mesh.
Control patients
Any patient undergoing a surgical procedure where fascial biopsy would not compromise the integrity of the procedure.

Detailed Description:

Several such biologic meshes have now been developed and marketed for use in hernia repair and soft tissue reconstruction. These biologics include one product derived from porcine intestinal submucosa (SurgisisTM, Cook Medical), another derived from porcine dermis (CollaMendTM, C.R. Bard Inc.) and several others derived from decellularized human dermis, such as AlloDermTM (LifeCell Corp.), AlloMaxTM (C.R. Bard Inc.), and FlexHDTM (Musculoskeletal Transplant Foundation). Although similar in concept and design, each of these biologic meshes is produced in a distinct, proprietary fashion, and different techniques are used by each company in the processing and storage of their respective products. Given that these processing steps are protected industrial intellectual property, rigorous comparison of the performance of each mesh is very difficult. It is expected that certain methods, such as employing or avoiding chemical cross-linking of the ECM proteins, would lead to significant differences in cell migration into, and biochemical remodeling of each individual mesh. These differences may be of particular importance in the scenario of laparoscopic ventral hernia repair, where the mesh is placed in direct apposition to the parietal peritoneum. In this case, if the biologic were to remodel and take on more of the properties of the distensible peritoneum rather than that of the stronger abdominal wall fascia, this could have a significant impact on the long-term strength and durability of the hernia repair. A similar situation could also be foreseen to occur at the esophageal hiatus and/or the site of an intestinal stoma. We feel that it is thus important to study the remodeling processes that these meshes undergo over time and determine if differences in product processing or anatomical position have any effect on mesh incorporation and hernia integrity. Many of these meshes have already been used in human subjects, yet a certain number of these patients are known have suffered hernia recurrences requiring reoperation and removal of some or all of the original mesh prostheses. It is our belief that these biologic explants represent an excellent source of material to study the remodeling process over numerous given time points and at various anatomic locations. We feel it is also important to compare the explanted biologic meshes to "control" tissues, to examine how successfully the biologic meshes are mimicking native tissue at the molecular and histologic level. To eliminate confounding factors, explanted meshes will be compared to biopsies of abdominal wall fascia from patients undergoing non-hernia related surgical procedures.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be selected from the practices of the surgeons listed on the investigational team.

Criteria

Inclusion Criteria:

  • All patients undergoing a repeat operation to repair a recurrent hernia or revise a surgical site which has been previously repaired using one of the aforementioned biologic meshes. Any patient undergoing a surgical procedure where fascial biopsy would not compromise the integrity of the procedure.

Exclusion Criteria:

  • For those subjects meeting the inclusion criteria, the only population that will be excluded is that of prisoners.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060046

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Musculoskeletal Transplant Foundation
Investigators
Principal Investigator: Brent D Matthews, MD Washington University School of Medicine
Study Director: Corey Deeken, PhD Washington University School of Medicine
  More Information

Publications:

Responsible Party: Brent Matthews, MD, Washington University School of Medicine, Department of Surgery, Section of Minimally Invasive Surgery
ClinicalTrials.gov Identifier: NCT01060046     History of Changes
Other Study ID Numbers: HRPO 06-1151
Study First Received: January 28, 2010
Last Updated: January 28, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
biologic mesh
ventral hernia repair
breast reconstruction
MMPs

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 24, 2014