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This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery.
Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phasix™ Mesh | Experimental | Prophylactic onlay placement of mesh. |
|
| Primary Suture Closure | No Intervention | Standard Fascial closure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phasix™ Mesh | Device | Phasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Incisional Hernia | The primary endpoint of the trial is the occurrence of incisional hernia in each treatment group (Phasix™ Mesh or Control Group) | 24-Months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Incisional Hernia | Rate of incisional hernia at each follow up time point | 60-Months |
| Rate of Device-related Adverse Events (AEs) | Rate of Device-related Adverse Events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Resendes, MBA | Contact | 401-209-7141 | amanda.resendes@bd.com | |
| Jaime Ritter, MPH | Contact | 404-327-1221 | jaime.ritter@bd.com |
| Name | Affiliation | Role |
|---|---|---|
| William Hope, MD | New Hanover Regional Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dignity Health | Recruiting | Phoenix | Arizona | 85013 | United States |
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| 60-Months |
| Length of surgical procedure in minutes | Length of surgical procedure in minutes | Study Day 0 |
| Length of time for wound closure in minutes | Length of time for wound closure in minutes | Study Day 0 |
| Length of hospital stay in days | Length of hospital stay in days | Through hospital stay, typically 3 days |
| Quality of Life: Optum Short Form Survey 12 Item Version 2 (SF-12v2®) | Health-related quality of life will be measured using the Optum SF-12v2. The questionnaire consists of 12 items weighted and summed to provide physical and mental health scores from the subject's perspective (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better quality of life. | 60-Months |
| Quality of Life: EuroQoL-5 Dimensions-3 Level (EQ-5D-3L©) | EuroQoL-Five Dimensions questionnaire-using Three Levels EQ-5D-3L is a standardized instrument for measuring generic health status. It consists of two components; health status description and evaluation. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension ranging from 1-3. From these five dimensions, EQ-5D index is calculated, having a value between 0-1. The evaluation part involves visual analogue scale, asking the subject to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. Zero corresponds to " the worst health you can imagine", and hundred corresponds to "the best health you can imagine". | 60-months |
| Keck Medical Center of USC | Withdrawn | Los Angeles | California | 90033 | United States |
| University of California San Francisco | Recruiting | San Francisco | California | 94143 | United States |
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| Hartford Hospital | Active, not recruiting | Hartford | Connecticut | 06102 | United States |
| St. Francis Hospital and Medical Center | Withdrawn | Hartford | Connecticut | 06105 | United States |
| Emory University | Terminated | Atlanta | Georgia | 30322 | United States |
| OSF Saint Francis Medical Center | Active, not recruiting | Peoria | Illinois | 61637 | United States |
| Indiana University | Active, not recruiting | Indianapolis | Indiana | 46202 | United States |
| University of Kentucky Research Foundation | Recruiting | Lexington | Kentucky | 40508 | United States |
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| Tulane University School of Medicine | Recruiting | New Orleans | Louisiana | 70112 | United States |
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| Boston Medical Center | Recruiting | Boston | Massachusetts | 02118 | United States |
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| University of Michigan | Withdrawn | Ann Arbor | Michigan | 48109 | United States |
| Minneapolis VA Health Care System | Withdrawn | Minneapolis | Minnesota | 55417 | United States |
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| St. Luke's Hospital | Withdrawn | Kansas City | Missouri | 64111 | United States |
| Cox Health | Withdrawn | Springfield | Missouri | 65807 | United States |
| Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
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| Nebraska Medical Center | Withdrawn | Omaha | Nebraska | 68106 | United States |
| Nebraska Methodist Hospital | Withdrawn | Omaha | Nebraska | 68114 | United States |
| Rutgers Cancer Institute of New Jersey | Recruiting | New Brunswick | New Jersey | 08901 | United States |
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| New York Presbyterian Hospital-Columbia University Medical Center | Active, not recruiting | New York | New York | 10032 | United States |
| Montefiore Medical Center | Active, not recruiting | The Bronx | New York | 10467 | United States |
| Atrium Health | Active, not recruiting | Charlotte | North Carolina | 28203 | United States |
| Duke University | Withdrawn | Durham | North Carolina | 27708 | United States |
| New Hanover Regional Medical Center | Recruiting | Wilmington | North Carolina | 28401 | United States |
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| The Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
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| Oregon Health & Science University | Withdrawn | Portland | Oregon | 97239 | United States |
| University of Pennsylvania | Active, not recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Baptist Clinical Research Institute | Active, not recruiting | Memphis | Tennessee | 38163 | United States |
| Vanderbilt University | Recruiting | Nashville | Tennessee | 37232 | United States |
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| CAMC Health Education and Research Institute, Inc. | Active, not recruiting | Charleston | West Virginia | 25304 | United States |
| Krankenhaus der Barmherzigen Brüder Graz | Recruiting | Graz | 08020 | Austria |
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| Universitair Ziekenhuis Gent | Recruiting | Ghent | 09000 | Belgium |
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| CHU de Dijon Bourgogne | Recruiting | Dijon | 21079 | France |
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| Centre Hospitalier Universitaire de Lille | Recruiting | Lille | 59000 | France |
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| Centre Hospitalier Universitaire de Lille | Recruiting | Lille | 59000 | France |
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| Hôpital Paris St Joseph | Recruiting | Paris | 75014 | France |
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| Hôpital Lyon Sud | Recruiting | Pierre-Bénite | 69495 | France |
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| CHU Reims | Recruiting | Reims | 51092 | France |
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| Hopitaux Universitaires de Strasbourg | Recruiting | Strasbourg | 67000 | France |
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| Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Gyneocology | Withdrawn | Berlin | 13353 | Germany |
| Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Surgery | Withdrawn | Berlin | 13353 | Germany |
| Asklepios Klinik Barmbek | Recruiting | Hamburg | 22307 | Germany |
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| Universitätsklinikum Heidelberg | Recruiting | Heidelberg | 69120 | Germany |
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| Bundeswehrzentralkrankenhaus Koblenz | Recruiting | Koblenz | 56072 | Germany |
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