Analysis and Characterization of Biologic Implants

May 7, 2018 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
241

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Musculoskeletal Transplant Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brent D Matthews, MD, Washington University School of Medicine
  • Study Director: Corey Deeken, PhD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201101959

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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