Ventral Hernia
Conditions
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.
Interventions
DEVICEStrattice Arm
Biologic mesh to be placed during hernia repair surgery
DEVICEBio-A Arm
Bioabsorbable mesh to be placed during hernia repair surgery
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hernia Recurrence | 3 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Bio-A Arm: Bioabsorbable mesh to be placed during hernia repair surgery | 0 |
| 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..
Strattice Arm: Biologic mesh to be placed during hernia repair surgery | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 0 |
| Overall Study | Lost to Follow-up | 6 | 9 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Sex/Gender, Customized Gender Not Identified | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 8 | 0 / 9 |
| other Total, other adverse events | 0 / 8 | 0 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 |
Outcome results
Primary
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
Population: The study was terminated before reaching full enrollment needed for analysis. Per https://clinicaltrials.gov/ct2/manage-recs/faq#terminated (accessed on 1.31.2019) we have indicated 0 for each study arm. No analyses were performed as the study was terminated due to lack of enrollment and patients lost to follow up and therefore no data was able to be collected for analysis.