Analysis and Characterization of Biologic Implants

Completed

Conditions studied: Ventral Hernia, Post-mastectomy Breast Reconstruction

In brief

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.

Key facts

Study ID

NCT01060046

Run by

Washington University School of Medicine

People needed

241

Starts

2007-08-01

Expected to finish

2017-01-01

Last updated by the study team

2018-05-14

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• For those subjects meeting the inclusion criteria, the only population that will be excluded is that of prisoners.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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