Clinical trial NCT01794338: The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2013-02-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Hernia Recurrence
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health - Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Brant T Heniford, MD
role: PRINCIPAL_INVESTIGATOR
References: