Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh (CVHR)
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|ClinicalTrials.gov Identifier: NCT02041494|
Recruitment Status : Terminated (Rising costs have made continuing the study untenable)
First Posted : January 22, 2014
Results First Posted : April 14, 2021
Last Update Posted : April 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hernia, Ventral||Device: Ventralight Device: Strattice||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Actual Study Start Date :||March 2014|
|Actual Primary Completion Date :||October 5, 2019|
|Actual Study Completion Date :||October 5, 2019|
Active Comparator: Synthetic
Patients in this arm will have their ventral hernia repaired utilizing Ventralight, a synthetic prosthetic mesh made of polypropylene.
Active Comparator: Biologic
Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis.
- Number of Patients Who Had a Recurrence of Hernia, at Anytime, up to Two Years Following Repair. [ Time Frame: up to 24 months after surgery ]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.
- Number of Patients Who Experienced Surgical Site Infections. [ Time Frame: 30 days after surgery ]Number of patients who experienced surgical site infections as determined by physical examination.
- 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.
- Number of Surgical Site Occurrences [ Time Frame: Up to two years from surgery ]Number of surgical site occurrences by type.
- Number of Other Surgical Complications [ Time Frame: 30 days after surgery ]Number of other surgical complications including: urinary tract infections, pneumonia, and Deep Vein Thrombosis/pulmonary embolism.
- 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.
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
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94131|
|Principal Investigator:||Hobart W. Harris, M.D., M.P.H.||University of California, San Francisco|