Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Carolinas Healthcare System
Information provided by (Responsible Party):
Todd Heniford, Carolinas Healthcare System Identifier:
First received: February 15, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted

This study evaluates the outcomes of patients who have been treated with Strattice or Gore Bio-A mesh for the repair of complicated abdominal wall hernias. The purpose of this study is to collect information and evaluate the outcome of your surgery. Synthetic (man made) mesh has been shown to provide durable long-term outcomes; however, this type of mesh should not be used in patients at risk of developing an infection. Therefore, to address the challenge of finding an artificial strengthening material to repair complicated hernias in patients that could potentially develop surgical infection, two types of non-permanent materials have been developed, including biologics and bioabsorbables. Biologic mesh is made of living tissue and bioabsorbable mesh is made of synthetic material that is gradually absorbed by the body over time. The purpose of this study is to allow surgeons to compare the postoperative course of patients associated with these two mesh types to decide which material will improve the outcomes of their patients with complicated abdominal wall defects. To date there is no evidence to suggest that either mesh type is superior or safer than the other.

Condition Intervention
Ventral Hernia
Device: Strattice Biologic Mesh Placement
Device: Bio-A Bioabsorbable Mesh Placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, Double Blind Clinical Trial of Non-cross-linked Porcine Dermis vs. Bioabsorbable Synthetic Mesh for the Repair of Abdominal Wall Defects in At-risk Patients

Resource links provided by NLM:

Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • Hernia Recurrence [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 96
Study Start Date: November 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bio-A Arm Device: Bio-A Bioabsorbable Mesh Placement
Bioabsorbable mesh to be placed during hernia repair surgery
Active Comparator: Strattice Arm Device: Strattice Biologic Mesh Placement
Biologic mesh to be placed during hernia repair surgery


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 or older
  • Grade II or III ventral hernia according to Ventral Hernia Working Group (VHWG)
  • Pre-operative informed consent is obtainable

Exclusion Criteria:

  • Return to the operating room within the next 1 year for additional open abdominal surgery is anticipated
  • Absence of fascial defect or fascial defect less than 3 cm in greatest dimension
  • Presence of previously place mesh (synthetic or biologic) at the site of surgery, which will not be completely removed and will, in part or whole, remain at the site of implantation of the study mesh
  • Concurrent placement of another mesh (synthetic or biologic) at the site where the study mesh is placed
  • Grade IV ventral hernia according to VHWG system
  • ASA score IV or above
  • Any disease or condition along with the surgeon's clinical judgment that contraindicates the use of either study mesh
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01794338

Contact: Amy E Lincourt, PhD 704-355-8787

United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Amy E Lincourt, PhD    704-355-8787   
Contact: Amanda L Walters, MS    704-355-7404   
Principal Investigator: Todd Heniford, MD         
Sponsors and Collaborators
Carolinas Healthcare System
Principal Investigator: Todd Heniford, MD Carolinas Medical Center
  More Information

No publications provided

Responsible Party: Todd Heniford, Chief, Gastrointestinal and Minimally Invasive Surgery, Carolinas Healthcare System Identifier: NCT01794338     History of Changes
Other Study ID Numbers: 09-12-02A
Study First Received: February 15, 2013
Last Updated: February 15, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hernia, Ventral
Hernia, Abdominal
Pathological Conditions, Anatomical processed this record on November 24, 2014