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Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh

Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hernia, Ventral

Intervention: Ventralight (Device); Strattice (Device)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Hobart Harris

Official(s) and/or principal investigator(s):
Hobart W. Harris, M.D., M.P.H., Principal Investigator, Affiliation: University of California, San Francisco

Overall contact:
Uk Sok Shin, Phone: 415-502-0339, Email: uksok.shin@ucsf.edu

Summary

Hernias are often treated using a prosthetic mesh to add support to the healing wound. Prosthetic meshes have been used for decades to repair ventral hernias, level 1 data regarding which type of mesh to use is limited. The purpose of this study is to compare the effects, good and/or bad, of two types of prosthetic meshes: one that is made from pig skin (called a "biologic prosthetic"), and one that is made in a laboratory (called a "synthetic prosthetic"). This study will include some patients who have an infection in/near the hernia, and other patients who do not have an infection. We expect the synthetic mesh to be associated with a higher rate of early post-operative surgical site infection and fluid collections (seromas), while we expect the biologic mesh to be associated with a higher rate of recurrence.

Clinical Details

Official title: Study Comparing the Efficacy, Safety, and Cost of a Permanent, Synthetic Prosthetic Versus a Biologic Prosthetic in the One-stage Repair of Ventral Hernias in Clean and Contaminated Wounds.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Recurrence

Secondary outcome: Wound Events

Detailed description: This is a prospective, single-blind, randomized study comparing the clinical efficacy and overall costs of two prosthetic meshes in the repair of complex ventral hernias. The two prosthetic meshes to be studied are Ventralight (Bard, Murray Hill, NJ), a synthetic mesh chiefly made of polypropylene and Strattice (LifeCell, Branchburg, NJ), a biologic mesh derived from porcine dermis. The study population will consist of patients who are in need of a repair of a complex ventral hernia. Patients will be enrolled in the study for 24 months following their operation or until they experience a recurrence of their hernia, whichever occurs first. The primary outcome variable is recurrence and the secondary outcome variables are post-operative surgical site infections and overall costs. There is no universally agreed upon definition of what constitutes a "complex" ventral hernia. For our purposes, a "complex" ventral hernia is one that involves a compromised surgical field, in which gastrointestinal, biliary, or genitourinary procedures are performed, one in which the wound class is considered clean-contaminated, contaminated, or dirty due to other causes, such as infected meshes and enterocutaneous fistulas, or surgical procedures conducted in patients with large ventral hernia defects (>10 cm in any single dimension).

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Clinical evidence of a midline, ventral hernia, regardless of degree of wound

contamination, with the exception of class IV wounds due to the presence/discovery of fecal peritonitis. Specifically, the repair will or will not involve a compromised surgical field in which gastrointestinal, biliary and/or genitourinary procedures will be performed. The surgical wound class may be classified as clean, or it may be classified as clean-contaminated, contaminated, or dirty-infected, due to the repair of an enterocutaneous fistula, takedown of an intestinal stoma and/or removal of infected mesh

- Age >21

- Negative pregnancy test

- No allergic, religious or ethical objections to either polypropylene or porcine

prosthetics

- Signed, witnessed informed consent to take part in the study

Exclusion Criteria:

- Lactating women

- Patients who are unable to commit to the follow evaluations over 24 months

- Severe malnutrition (serum albumin <2. 0 in the setting of a normal CRP)

- Use of an investigational agent within 1 month prior to study enrollment and/or

planned during this study

- Presence of pre-existing parenchymal liver disease characterized by the presence of

Child's Class C liver dysfunction (including all of the following: bilirubin ≥ 3. 0 mg/dL; albumin ≤ 3. 0 mg/dL; refractory ascites; encephalopathy or coma; and poor nutritional status)

- Immunocompromised patients, as evidenced by: administration of high doses of

corticosteroids (i. e. doses ≥ 1. 5 mg/kg/day of prednisone or equivalent) within 72 hours before study enrollment; status post solid organ transplant or bone marrow transplant and experiencing acute organ rejection or bone marrow failure or rejection; evidence of neutropenia (absolute neutrophil count ≤ 500 cells/mm3 (≤ 500 x 106 cells/L); chemotherapy or radiation therapy within 90 days before study enrollment; known AIDS; any disease sufficiently advanced to suppress resistance to infection (including, but not limited to leukemia, lymphoma or hypogammaglobulinemia); administration of immunoglobulin of G-CSF within 90 days before study enrollment

- Ascites refractory to medical management

- Presence of an underlying disease/injury with life expectancy less than two years

and/or severe underlying disease that would preclude study entry (e. g. known malignancy)

- Wound Classification IV due to the presence/discovery of fecal peritonitis. Other

cases of wound class IV including presence of purulent inflammation, soft tissue/mesh infection, or visceral perforation resulting in a contained fistula (e. g. enterocutaneous fistula) are still considered eligible for enrollment.

Locations and Contacts

Uk Sok Shin, Phone: 415-502-0339, Email: uksok.shin@ucsf.edu

University of California, San Francisco, San Francisco, California 94131, United States; Recruiting
Uk Sok Shin, Phone: 415-502-0339, Email: uksok.shin@ucsf.edu
Michael Tufaga, M.D., Phone: 415-502-0339, Email: michael.tufaga@ucsf.edu
David Young, M.D., Sub-Investigator
Scott Hansen, M.D., Sub-Investigator
Chris Freise, M.D., Sub-Investigator
Hani Sbitany, M.D., Sub-Investigator
Hobart W. Harris, M.D., M.P.H., Principal Investigator
Esther Kim, M.D., Sub-Investigator
Jonathan Carter, M.D., Sub-Investigator
Additional Information

Starting date: March 2014
Last updated: May 26, 2015

Page last updated: August 23, 2015

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