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Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh (CVHR)

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ClinicalTrials.gov Identifier: NCT02041494
Recruitment Status : Recruiting
First Posted : January 22, 2014
Last Update Posted : October 26, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Hernia, Ventral Device: Ventralight Device: Strattice Phase 2 Phase 3

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).

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : March 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Synthetic
Patients in this arm will have their ventral hernia repaired utilizing Ventralight, a synthetic prosthetic mesh made of polypropylene.
Device: Ventralight
Other Names:
  • Ventralight ST Mesh
  • K101851
Active Comparator: Biologic
Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis.
Device: Strattice
Other Names:
  • LTM Surgical Mesh
  • K070560

Outcome Measures

Primary Outcome Measures :
  1. Recurrence [ Time Frame: 24 months after surgery ]
    The primary outcome measure is recurrence of the hernia. The hypothesis driving this study is that ventral hernia repairs using polypropylene mesh result in fewer recurrent hernias than repairs using a biologic prosthetic

Secondary Outcome Measures :
  1. Wound Events [ Time Frame: 24 months after surgery ]
    Wound events include surgical site infections as well as seromas/hematomas.

Other Outcome Measures:
  1. Quality of life [ Time Frame: 24 months after surgery ]
    Quality of life will be measured using the SF-36 and the HerQLes surveys.

  2. Early post-operative complications [ Time Frame: One month after surgery ]
    Early post-operative complications include urinary tract infection and sepsis.

  3. Pain [ Time Frame: 24 months after surgery ]
    Pain will be measured using the Visual Analog Scale for pain.

  4. Activity level [ Time Frame: 24 months after surgery ]
    Activity level will be measured using the Activity Assessment Scale.

  5. Overall cost [ Time Frame: 24 months after surgery ]
    Overall costs will be measured using a combination approach comparing actual costs, allowed vs. paid amounts, and Medicare payment rates using diagnosis related groups (DRG) and resource-based relative value scale (RBRVS) data.

Eligibility Criteria

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041494

Contact: Uk Sok Shin 415-502-0339 uksok.shin@ucsf.edu
Contact: Michael Tufaga, M.D. 415-502-0339 michael.tufaga@ucsf.edu

United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94131
Contact: Uk Sok Shin    415-502-0339    uksok.shin@ucsf.edu   
Contact: Michael Tufaga, M.D.    415-502-0339    michael.tufaga@ucsf.edu   
Sub-Investigator: David Young, M.D.         
Sub-Investigator: Scott Hansen, M.D.         
Sub-Investigator: Chris Freise, M.D.         
Sub-Investigator: Hani Sbitany, M.D.         
Principal Investigator: Hobart W. Harris, M.D., M.P.H.         
Sub-Investigator: Esther Kim, M.D.         
Sub-Investigator: Jonathan Carter, M.D.         
Sponsors and Collaborators
Hobart Harris
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Hobart W. Harris, M.D., M.P.H. University of California, San Francisco
More Information

Responsible Party: Hobart Harris, Professor, Chief of General Surgery, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02041494     History of Changes
Other Study ID Numbers: UCSF-NIDDK-1R21DK093006-01A1
1R21DK093006-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by Hobart Harris, University of California, San Francisco:

Additional relevant MeSH terms:
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal