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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Boston Medical Center | OTHER |
| Cook County Hospital | OTHER |
| University of Southern California |
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The rate of hernia recurrence at one year following repair of a large abdominal hernia with a biologic mesh is high, ranging from 30% to 100%, with a reported historic average rate of 40%. The purpose of this study is to evaluate the rate of hernia recurrence at one year following repair with SurgiMend 3.0, an FDA-cleared novel biologic mesh, the hypothesis being that such rate will be less than 20% at one year, representing a 50% reduction over the historic rate of 40%.
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| Measure | Description | Time Frame |
|---|---|---|
| Hernia recurrence | 1 year |
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Inclusion Criteria:
All three of the following criteria must be present for enrollment into the study:
Exclusion Criteria:
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Patients with surgical conditions such as i) open abdomen after a damage control operation for a traumatic or non-traumatic surgical emergency, ii) removal of infected prosthetic materials from a previous abdominal hernia repair, iii) iatrogenic injury of the bowel during adhisiolysis for repair of a large abdominal hernia, iv) contaminated operative field due to presence of an ostomy or the need for additional surgical procedures.
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| Name | Affiliation | Role |
|---|---|---|
| George C Velmahos, MD, Ph.D. | Massachusetts General Hospital/ Harvard University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles County/University of Southern California Medical Center | Los Angeles | California | 90033 | United States | ||
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| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
| Yale University | OTHER |
| Oregon Health and Science University | OTHER |
| State University of New York - Upstate Medical University | OTHER |
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| Yale University School of Medicine |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Cook County Hospital | Chicago | Illinois | 60612 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| State University of New York (SUNY), Upstate Medical Center | Syracuse | New York | 13210 | United States |
| Oklahoma University | Oklahoma City | Oklahoma | 73117 | United States |
| Oregon Health and Science University (OHSU) | Portland | Oregon | 97239 | United States |