The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2012 |
| End Date: | November 2018 |
| Contact: | Amy E Lincourt, PhD |
| Email: | amy.lincourt@carolinashealthcare.org |
| Phone: | 704-355-8787 |
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
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.
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.
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.
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.
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
We found this trial at
1
site
1000 Blythe Blvd
Charlotte, North Carolina 28203
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Todd Heniford, MD
Phone: 704-355-8787
Click here to add this to my saved trials
