Analysis and Characterization of Biologic Implants
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.
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 Design
Observational Model: Case Control, Time Perspective: Prospective
Conditions
Ventral Hernia
Location
Washington University School of Medicine
St. Louis
Missouri
United States
63110
Status
Enrolling by invitation
Source
Washington University School of Medicine
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01060046
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Hernia, Ventral
A hernia caused by weakness of the anterior ABDOMINAL WALL due to midline defects, previous incisions, or increased intra-abdominal pressure. Ventral hernias include UMBILICAL HERNIA, incisional, epigastric, and spigelian hernias.
Hernia, Abdominal
A protrusion of abdominal structures through the retaining ABDOMINAL WALL. It involves two parts: an opening in the abdominal wall, and a hernia sac consisting of PERITONEUM and abdominal contents. Abdominal hernias include groin hernia (HERNIA, FEMORAL; HERNIA, INGUINAL) and VENTRAL HERNIA.
Ventral Thalamic Nuclei
A large group of nuclei lying between the internal medullary lamina and the internal capsule. It includes the ventral anterior, ventral lateral, and ventral posterior nuclei.
Hernia, Obturator
A pelvic hernia through the obturator foramen, a large aperture in the hip bone normally covered by a membrane. Obturator hernia can lead to intestinal incarceration and INTESTINAL OBSTRUCTION.
Hernia, Femoral
A groin hernia occurring inferior to the inguinal ligament and medial to the FEMORAL VEIN and FEMORAL ARTERY. The femoral hernia sac has a small neck but may enlarge considerably when it enters the subcutaneous tissue of the thigh. It is caused by defects in the ABDOMINAL WALL.
Clinical Trials
Laparoscopic Intraperitoneal Mesh Repair of Ventral Hernia: Comparison to Conventional Mesh Repair
The laparoscopic repair of ventral hernias is still a controversial therapeutic option. To evaluate the efficacy and safety of laparoscopic repair we compare the results of the open and la...
Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-Trial)
1. General - antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery 2. Laparoscopic surgery - at least 5 cm o...
1. General: antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery 2. Laparoscopic surgery - at least 5 cm overlap (mesh...
This is a multi-center, observational study of incisional/ventral hernia repair with NG-TSM laparoscopically. The study is not randomized and has a single treatment design assessing NG-TSM...
LACH-Trial: LAparoscopic Correction of Hernia
Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might influence the degree of postoperative pain. The study hypothesis is that there is no difference in...
PubMed Articles
Direct and Recurrent Inguinal Hernias are Associated with Ventral Hernia Repair: A Database Study.
BACKGROUND: A systemically altered connective tissue metabolism has been demonstrated in patients with abdominal wall hernias. The most pronounced connective tissue changes are found in patients with...
Laparoscopic Ventral Hernia Repair.
Ventral hernias, whether naturally occurring or the result of previous surgery, comprise one of the most common problems confronting general surgeons. As many as 25% of laparotomy incisions develop a...
Ventral hernia mesh tack causes liver hemorrhage.
INTRODUCTION: The laparoscopic approach is an increasingly popular option for ventral hernia repair. In the wake of this new technology, unexpected complications have been reported. CASE PRESENTATION:...
Outcomes After Emergency Versus Elective Ventral Hernia Repair: A Prospective Nationwide Study.
BACKGROUND: Early surgical results after emergency repairs for the most frequent ventral hernias (epigastric, umbilical, and incisional) are not well described. Thus, the aim of present study was to i...
Flexible tack for ventral hernia repair.
A mesh repair of a ventral hernia from the anterior approach is relatively difficult because it is necessary to fix the edge of the mesh from the hernial orifice. We developed a flexible tack for hern...
