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Stopped early
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Support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in a diminished rate of hernia recurrence. The patient with co-morbidities undergoing hernia repair is at increased risk of wound related complications, which may be exacerbated by the choice of prosthetic mesh, and which are known to influence the ultimate rate of hernia recurrence. It is hypothesized that patients receiving a mesh of biologic origin may experience fewer wound related complications and hence at least an equal rate of hernia recurrence, compared to those receiving a synthetic mesh.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strattice Reconstructive Tissue Matrix | Experimental | Use of Strattice Reconstructive Tissue Matrix to support hernia repair |
|
| Proceed Surgical Mesh | Active Comparator | Use of Proceed Surgical Mesh to support hernia repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strattice Reconstructive Tissue Matrix (Hernia Repair) | Device | Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Surgical Site Events (SSEs) | Postoperative Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Martindale, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisiana Status University Health Sciences Center | New Orleans | Louisiana | 70112 | United States | ||
| Tulane University |
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23 subjects recruited from 9 US sites between August 2009 and May 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Strattice Reconstructive Tissue Matrix | Use of Strattice Reconstructive Tissue Matrix to support hernia repair |
| FG001 | Proceed Surgical Mesh | Use of Proceed Surgical Mesh to support hernia repair |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Proceed Surgical Mesh (Hernia repair) | Device | Hernia repair will be performed, in an open fashion and defect will be closed or reduced in size using musculofascial centralization procedures to reestablish midline. |
|
| New Orleans |
| Louisiana |
| 70115 |
| United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Boston Veterans Administration Healthcare System | West Roxbury | Massachusetts | 02132 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Truman Medical Center | Kansas City | Missouri | 64108 | United States |
| Long Island Jewish - North Shore | Lake Success | New York | 11042 | United States |
| University Hospital - Case Western | Cleveland | Ohio | 44106 | United States |
| Oregon Health Sciences University | Portland | Oregon | 97239 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 70115 | United States |
| Scott & White Medical Center | Temple | Texas | 76508 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Strattice Reconstructive Tissue Matrix | Use of Strattice Reconstructive Tissue Matrix to support hernia repair |
| BG001 | Proceed Surgical Mesh | Use of Proceed Surgical Mesh to support hernia repair |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Surgical Site Events (SSEs) | Study was terminated early and no analyses were conducted. | Posted | Postoperative Day 30 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Strattice Reconstructive Tissue Matrix | Use of Strattice Reconstructive Tissue Matrix to support hernia repair | 0 | 14 | 14 | 14 | ||
| EG001 | Proceed Surgical Mesh | Use of Proceed Surgical Mesh to support hernia repair | 1 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound Infection | Infections and infestations |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incisional drainage | Surgical and medical procedures |
| |||
| Wound dehiscence | Injury, poisoning and procedural complications |
| |||
| Atrial fibrillation | Cardiac disorders |
| |||
| Abdominal hernia | Gastrointestinal disorders |
| |||
| Localised intraabdominal fluid | Gastrointestinal disorders |
| |||
| Seroma | Injury, poisoning and procedural complications |
| |||
| International normalised ratio increased | Investigations |
| |||
| Urine output decreased | Investigations |
| |||
| Respiratory distress | Respiratory, thoracic and mediastinal disorders |
| |||
| Hypertension | Vascular disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Rectal haemorrhage | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Pyrexia | General disorders |
| |||
| Incision site infection | Infections and infestations |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Michael Franz | LifeCell | 908094701100 | mfranz@lifecell.com |
| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059685 | Herniorrhaphy |
| ID | Term |
|---|---|
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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| Male |
|