A Prospective Case Series Evaluating Surgimend Mp® In Patients Undergoing Complex Abdominal Hernia Repair
Hernia, Ventral
About this trial
This is an interventional other trial for Hernia, Ventral focused on measuring Mesh
Eligibility Criteria
Inclusion Criteria:
- Men or women ≥ 18 years of age and able to give their own consent.
- The subject is able and willing to comply with study procedures and a signed and dated informed consent is obtained.
- The subject has a complex ventral hernia
- The surgeon intends to use bioprosthetic mesh in the repair of the hernia
The hernia meets the definition of complex.
For this study a hernia defect will be considered complex if:
5.1. a hernia defect is large enough to require component separation to achieve midline fascial closure under physiologic tension 5.2. or the surgical wound is class II -potentially contaminated or class III - contaminated without signs of infection as defined by the CDC wound classification (see Table 1) 5.3. or a patient classified as at risk for surgical site complications by having 2 or more of the following comorbidities:
- Current smoker or recent history of smoking
- Obesity (BMI ≥ 30)
- Type I or Type II diabetes
- Chronic Obstructive Pulmonary Disease (COPD)
- Poor nutritional status as judged by the Investigator
- Current immunosuppressive therapy
- Current and/or recent (within 30 days of planned surgery) Corticosteriod use
- Prior Mesh infection
- Life expectancy of the patient is considered by the physician to be greater than at least 1 year
- The subject has no known hypersensitivity to bovine collagen
- The subject has no obvious condition interfering with their ability to comply with the treatment regimen
- The subject is willing and capable of returning for all follow-up evaluations, in the opinion of the treating physician
Exclusion Criteria:
Pre-Operative Exclusion:
- < 18 years of age
- Have abdominal loss of domain such that the operation would be impractical or would adversely affect respiratory or cardiovascular function to an unacceptable degree in the opinion of the Investigator
- Participation in an investigational drug or device study within the past 6 weeks prior to enrollment into this trial
- Have a known collagen metabolism disorder or any medical condition that could interfere with normal tissue healing process as determined by the Investigator
Intra-Operative Exclusion Criteria:
Subjects will be excluded from the study after the index operation if any of the following exclusion criteria are met:
- Primary closure of the skin and subcutaneous tissue is not achieved at the index operation
- Bioprosthetic mesh was not used in the repair for any reason
- Primary Fascial closure unable to be obtained i.e. bridged closure
- Unable to place the mesh in the retrorectus space (no intraperitoneal placement)
Sites / Locations
- Barnes Jewish Hospital
Arms of the Study
Arm 1
Other
SurgiMend® MP
Patients will not be randomized as this is a case series study involving the evaluation of only 1 type of mesh (SurgiMend MP®).