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 2015 by Carolinas Healthcare System
Sponsor:
Information provided by (Responsible Party):
Todd Heniford, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01794338
First received: February 15, 2013
Last updated: February 3, 2015
Last verified: February 2015
  Purpose

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 Arm
Device: Bio-A Arm

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
Patients will receive underlay mesh tissue reinforcement followed by standard fascial closure with #1 PDS. As described by Dr. Stoppa10-12, the mesh will be secured via abdominal wall sutures. Additional full thickness sutures will be placed every 8 cm circumferentially. After securing the mesh in place, #1 PDS sutures will be used to close the fascia in a running fashion with 1.5-2 cm "bites" from the fascial edge and a 1cm "walk" between stitches. Skin will be closed with staples or monofilament suture according to surgeon preference. Drains will be placed on the mesh in each case, and one or two drains will be placed in the subcutaneous tissues at the discretion of the surgeon depending on the amount of subcutaneous tissue dissected.
Device: Bio-A Arm
Bioabsorbable mesh to be placed during hernia repair surgery
Active Comparator: Strattice Arm
Patients will receive underlay mesh tissue reinforcement followed by standard fascial closure with #1 PDS. As described by Dr. Stoppa10-12, the mesh will be secured via abdominal wall sutures. Additional full thickness sutures will be placed every 8 cm circumferentially. After securing the mesh in place, #1 PDS sutures will be used to close the fascia in a running fashion with 1.5-2 cm "bites" from the fascial edge and a 1cm "walk" between stitches. Skin will be closed with staples or monofilament suture according to surgeon preference. Drains will be placed on the mesh in each case, and one or two drains will be placed in the subcutaneous tissues at the discretion of the surgeon depending on the amount of subcutaneous tissue dissected..
Device: Strattice Arm
Biologic mesh to be placed during hernia repair surgery

Detailed Description:

The goal of the proposed study is to evaluate the outcomes of patients implanted with Strattice® (LifeCell Corporation, Branchburg, NJ, USA) and Gore® Bio-A® (W. L. Gore & Associates, Inc., Newark, DE, USA) for the repair of abdominal wall defects in at-risk patients. Primary endpoints of the study will include hernia recurrence, duration of postoperative drains, the incidence of systemic and wound-related complications, the need for percutaneous intervention or reoperation and quality- of-life with 3 years of follow-up. The study will be prospective and randomized, and the evaluator and patient will be blinded as to the type of mesh implanted.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01794338

Contacts
Contact: Amy E Lincourt, PhD 704-355-8787 amy.lincourt@carolinashealthcare.org

Locations
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Amy E Lincourt, PhD    704-355-8787    amy.lincourt@carolinashealthcare.org   
Contact: Christine A Edmonds    704-355-9150    Christine.Edmonds@carolinashealthcare.org   
Principal Investigator: Todd Heniford, MD         
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
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
ClinicalTrials.gov Identifier: NCT01794338     History of Changes
Other Study ID Numbers: 09-12-02A
Study First Received: February 15, 2013
Last Updated: February 3, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hernia, Ventral
Hernia
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 03, 2015