Clinical Trial: Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Co

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 Summary:

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).


Sponsor: Hobart Harris

Current Primary Outcome: 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: Same as current

Current Secondary Outcome: Wound Events [ Time Frame: 24 months after surgery ]

Wound events include surgical site infections as well as seromas/hematomas.


Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: January 18, 2014
Date Started: March 2014
Date Completion: June 2019
Last Updated: October 24, 2016
Last Verified: October 2016