Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh

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.

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
Phase 2/Phase 3 Interventional 21 Years and older Hobart Harris UCSF-NIDDK-1R21DK093006-01A1
1R21DK093006-01A1
NCT02041494
Enrolling patients

Study Design:


Principal Investigator

Professor and Chief, Division of General Surgery
Vice-Chair, Department of Surgery
J. Engelbert Dunphy Endowed Chair in Surgery
Director, Center for Hernia Repair & Abdominal Wall Reconstruction
Director, Infection, Injury & Immunity Lab
Program Director, NIH T32 Training Program in Gastrointestinal Surgery

Michael A. Tufaga, MD
Department of Surgery
513 Parnassus Ave, HSE 590, Box 0660
San Francisco, CA 94143-0660
Michael.Tufaga@ucsf.edu

Uk Sok Shin
513 Parnassus Ave, Room 590
San Francisco, CA 94143
(415) 502-0339
UkSok.Shin@ucsf.edu

Sophia Fong
513 Parnassus Ave, Room 590
San Francisco, CA 94143
Sophia.Fong@ucsf.edu


Trial 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.

Eligibility

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.

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).

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 1/26/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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