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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Hernia, Ventral
• Intervention / Treatment: Device: Ventralight; Device: Strattice

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: Interventional
• Enrollment (Actual): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94131
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Who Had a Recurrence of Hernia, at Anytime, up to Two Years Following Repair.	Number of patients who had a recurrence of hernia, at anytime, up to two years following repair as determined by physical examination, ultrasound or CT scan.	up to 24 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Who Experienced Surgical Site Infections.	Number of patients who experienced surgical site infections as determined by physical examination.	30 days after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generic Measure of Health-related Quality of Life and Hernia-specific Measure of Quality of Life With a Focus on Abdominal Wall Function	Quality of life will be measured using the SF-36 and the HerQLes surveys.	24 months after surgery
Number of Surgical Site Occurrences	Number of surgical site occurrences by type.	Up to two years from surgery
Number of Other Surgical Complications	Number of other surgical complications including: urinary tract infections, pneumonia, and Deep Vein Thrombosis/pulmonary embolism.	30 days after surgery
Activity Level	Activity level will be measured using the Activity Assessment Scale.	24 months after surgery
Overall Cost	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.	24 months after surgery

Collaborators and Investigators

• Sponsor: Hobart Harris
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Hobart W. Harris, M.D., M.P.H., University of California, San Francisco

Publications and helpful links

General Publications

• Harris HW, Primus F, Young C, Carter JT, Lin M, Mukhtar RA, Yeh B, Allen IE, Freise C, Kim E, Sbitany H, Young DM, Hansen S. Preventing Recurrence in Clean and Contaminated Hernias Using Biologic Versus Synthetic Mesh in Ventral Hernia Repair: The PRICE Randomized Clinical Trial. Ann Surg. 2021 Apr 1;273(4):648-655. doi: 10.1097/SLA.0000000000004336.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): October 5, 2019
• Study Completion (Actual): October 5, 2019

Study Registration Dates

• First Submitted: January 18, 2014
• First Submitted That Met QC Criteria: January 18, 2014
• First Posted (Estimate): January 22, 2014

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Infection; Recurrence; Biologic; Herniorrhaphy; Hernia; Mesh; Abdominal; Synthetic; Ventral; Incisional
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: UCSF-NIDDK-1R21DK093006-01A1; 1R21DK093006-01A1 (U.S. NIH Grant/Contract)