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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02041494
Recruitment Status : Terminated (Rising costs have made continuing the study untenable)
First Posted : January 22, 2014
Last Update Posted : October 31, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Hobart Harris, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE January 18, 2014
First Posted Date  ICMJE January 22, 2014
Last Update Posted Date October 31, 2018
Actual Study Start Date  ICMJE March 2014
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02041494 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2014)
Wound Events [ Time Frame: 24 months after surgery ]
Wound events include surgical site infections as well as seromas/hematomas.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 29, 2018)
  • Generic measure of health-related quality of life and hernia-specific measure of quality of life with a focus on abdominal wall function [ Time Frame: 24 months after surgery ]
    Quality of life will be measured using the SF-36 and the HerQLes surveys.
  • Early post-operative complications [ Time Frame: One month after surgery ]
    Early post-operative complications include urinary tract infection and sepsis.
  • Acute abdominal pain [ Time Frame: 24 months after surgery ]
    Pain will be measured using the Visual Analog Scale for pain.
  • Activity level [ Time Frame: 24 months after surgery ]
    Activity level will be measured using the Activity Assessment Scale.
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: January 18, 2014)
  • Quality of life [ Time Frame: 24 months after surgery ]
    Quality of life will be measured using the SF-36 and the HerQLes surveys.
  • Early post-operative complications [ Time Frame: One month after surgery ]
    Early post-operative complications include urinary tract infection and sepsis.
  • Pain [ Time Frame: 24 months after surgery ]
    Pain will be measured using the Visual Analog Scale for pain.
  • Activity level [ Time Frame: 24 months after surgery ]
    Activity level will be measured using the Activity Assessment Scale.
  • 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.
 
Descriptive Information
Brief Title  ICMJE Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh
Official Title  ICMJE 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.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Hernia, Ventral
Intervention  ICMJE
  • Device: Ventralight
    Other Names:
    • Ventralight ST Mesh
    • K101851
  • Device: Strattice
    Other Names:
    • LTM Surgical Mesh
    • K070560
Study Arms  ICMJE
  • Active Comparator: Synthetic
    Patients in this arm will have their ventral hernia repaired utilizing Ventralight, a synthetic prosthetic mesh made of polypropylene.
    Intervention: Device: Ventralight
  • Active Comparator: Biologic
    Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis.
    Intervention: Device: Strattice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 19, 2018)
166
Original Estimated Enrollment  ICMJE
 (submitted: January 18, 2014)
330
Actual Study Completion Date  ICMJE September 2018
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02041494
Other Study ID Numbers  ICMJE UCSF-NIDDK-1R21DK093006-01A1
1R21DK093006-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hobart Harris, University of California, San Francisco
Study Sponsor  ICMJE Hobart Harris
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Hobart W. Harris, M.D., M.P.H. University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP