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
|Condition or disease||Intervention/treatment||Phase|
|Hernia, Ventral||Device: Ventralight Device: Strattice||Phase 2 Phase 3|
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)|
|Estimated Enrollment :||330 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.|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2020|
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.
- 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
- Wound Events [ Time Frame: 24 months after surgery ]Wound events include surgical site infections as well as seromas/hematomas.
- 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.
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 Shinemail@example.com|
|Contact: Michael Tufaga, M.D.||firstname.lastname@example.org|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94131|
|Contact: Uk Sok Shin 415-502-0339 email@example.com|
|Contact: Michael Tufaga, M.D. 415-502-0339 firstname.lastname@example.org|
|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.|
|Principal Investigator:||Hobart W. Harris, M.D., M.P.H.||University of California, San Francisco|