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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
28
Biologic mesh to be placed during hernia repair surgery
Bioabsorbable mesh to be placed during hernia repair surgery
Atrium Health - Carolinas Medical Center
Charlotte, North Carolina, United States
Hernia Recurrence
Patients will undergo post-operative follow-up at 1 month, 6 months, and yearly for 3 years. Patients will receive reminders of their follow-up visits before each time period. At each visit, patients will be asked to fill out a short questionnaire (Form A and Form B) that will aid in assessing and documenting postoperative symptoms and quality of life. During each follow-up visit a board certified or board eligible surgeon, who is blinded with regard to the group assignment, will perform a physical examination to assess for the presence of a recurrent hernia, eventration and other findings detailed on Form C. Any signs of wound complications will be noted, including seroma formation, erythema, drainage, break in the skin, purulence or tenderness to palpation. If a recurrent hernia defect is identified on the physical examination, imaging studies will be performed as indicated. Once a hernia defect is found, further management options will be discussed with the patient.
Time frame: 3 years
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