Analysis and Characterization of Biologic Implants

2014-08-27 03:16:15 | BioPortfolio


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.


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


Ventral Hernia


Washington University School of Medicine
St. Louis
United States


Enrolling by invitation


Washington University School of Medicine

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:16:15-0400

Clinical Trials [330 Associated Clinical Trials listed on BioPortfolio]

Robotic Versus Laparoscopic Ventral Hernia Repair

Ventral hernias are a common disease and one half of all individuals are born with or will acquire a ventral hernia in their lifetime. Repair of ventral hernias may be associated with sign...

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...

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Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair

The current study aims to determine if transverse abdominis plane block using local anesthetic agents (bupivacaine 0.25% + Ropivacaine 0.20%) decreases the post operative pain and helps in...

Modifying Risk in Ventral Hernia Patients

A pre-operative physical conditioning and weight loss intervention (prehabilitation) compared to standard counseling prior to ventral hernia repair for obese patients (BMI 30-40 kg/m2) at ...

PubMed Articles [747 Associated PubMed Articles listed on BioPortfolio]

Modifying Risks in Ventral Hernia Patients With Prehabilitation: A Randomized Controlled Trial.

The aim of this study was to determine whether preoperative nutritional counseling and exercise (prehabilitation) in obese patients with ventral hernia repair (VHR) results in more hernia-free and com...

Laparoscopic versus open emergent ventral hernia repair: utilization and outcomes analysis using the ACSNSQIP database.

Laparoscopic ventral hernia repair (VHR) is associated with decreased morbidity and shorter length of stay (LOS) when compared to open VHR. Despite evidence of the benefits of laparoscopy, its utiliza...

Deciding on Optimal Approach for Ventral Hernia Repair: Laparoscopic or Open.

The decision to perform laparoscopic (L) or open (O) ventral hernia repair (VHR) is multifactorial. This study evaluates the impact of operative approach, BMI and hernia size on outcomes after VHR.

Complex Ventral Hernia Repair in the Class III Morbidly Obese Patient.

Patients undergoing complex ventral hernia repair (VHR) often present with significant medical comorbidities, the most prevalent of which is obesity. Although recent advancements in abdominal wall rec...

Concomitant ventral hernia repair and bariatric surgery: a retrospective analysis from a UK-based bariatric center.

Ventral hernias (VH) are frequently encountered in patients with morbid obesity. Concomitant ventral hernia repair (VHR) and bariatric surgery (BS) is practiced but still controversial. Wound-related ...

Medical and Biotech [MESH] Definitions

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.

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.

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.

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.

A HERNIA due to an imperfect closure or weakness of the umbilical ring. It appears as a skin-covered protrusion at the UMBILICUS during crying, coughing, or straining. The hernia generally consists of OMENTUM or SMALL INTESTINE. The vast majority of umbilical hernias are congenital but can be acquired due to severe abdominal distention.

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