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| ID | Type | Description | Link |
|---|---|---|---|
| 04-007 |
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| Name | Class |
|---|---|
| Cook Biotech Incorporated | INDUSTRY |
| MED Institute, Incorporated | INDUSTRY |
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The primary objective is to compare the effectiveness of the Surgisis Gold Graft to suture closure alone in preventing an incisional hernia after open bariatric surgery.
This will be a prospective, randomized clinical trial comparing outcomes of use of a sublay of Surgisis Gold Graft for tissue reinforcement, as compared to suture closure alone in evaluating incidence of incisional hernias. Prior to undergoing open bariatric surgery, patients will be randomized to receive either Surgisis Gold Graft or suture closure alone. Subjects will be seen for follow-up visits at six weeks, three months, six months, one year and two years post-operatively. Patients may see their primary care physician for the one and two follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Surgisis Gold Graft |
|
| 2 | Active Comparator | Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgisis Gold Graft | Device | Surgisis Gold Graft is placed as an underlay following open bariatric surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incisional Hernia | An obvious defect or interruption of the fascia in the area of the incision that was palpable on clinical examination and/or visible by a cross-sectional imaging modality. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Sarr, MD | Mayo Clinic Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Foundation | Rochester | Minnesota | 55905 | United States | ||
| St. Mary's Medical |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25239343 | Result | Sarr MG, Hutcher NE, Snyder S, Hodde J, Carmody B. A prospective, randomized, multicenter trial of Surgisis Gold, a biologic prosthetic, as a sublay reinforcement of the fascial closure after open bariatric surgery. Surgery. 2014 Oct;156(4):902-8. doi: 10.1016/j.surg.2014.06.022. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgisis Gold | Surgisis Gold Graft is placed as an underlay following open bariatric surgery. |
| FG001 | Suture Closure | Control : Incision is closed without the placement of a graft material (standard of care control) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
14 patients in Surgisis Gold group and 8 patients in Suture Closure group were excluded from the analysis, because prior to procedure, either they were found not to meet the inclusion/exclusion criteria, or they chose not to participate.
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| ID | Title | Description |
|---|---|---|
| BG000 | Surgisis Gold | Surgisis Gold Graft is placed as an underlay following open bariatric surgery. |
| BG001 | Suture Closure | Control : Incision is closed without the placement of a graft material (standard of care control) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Incisional Hernia | An obvious defect or interruption of the fascia in the area of the incision that was palpable on clinical examination and/or visible by a cross-sectional imaging modality. | 14 patients in Surgisis Gold group and 8 patients in Suture Closure group were excluded from the analysis, because prior to procedure, either they were found not to meet the inclusion/exclusion criteria, or they chose not to participate. | Posted | Number | participants | 2 years |
|
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14 patients in Surgisis Gold group and 8 patients in Suture Closure group were excluded from the analysis, because prior to procedure, either they were found not to meet the inclusion/exclusion criteria, or they chose not to participate.
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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 | Surgisis Gold | Surgisis Gold Graft is placed as an underlay following open bariatric surgery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Hodde, Clinical Affairs Manager | Cook Biotech Incorporated | 765-497-3355 | jhodde@cookbiotech.com |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| D009765 | Obesity |
| D000069290 | Incisional Hernia |
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| Control | Procedure | Incision is closed without the placement of a graft material (standard of care control) |
|
| Richmond |
| Virginia |
| 23226 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI (Body mass index) | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| 0 |
| 185 |
| 87 |
| 185 |
| EG001 | Suture Closure | Control : Incision is closed without the placement of a graft material (standard of care control) | 0 | 195 | 62 | 195 |
| Wound infection | Infections and infestations | Systematic Assessment |
|
| Wound erythema requiring antibiotics | Infections and infestations | Systematic Assessment |
|
| Incisional hernia | Infections and infestations | Systematic Assessment |
|
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| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D046449 | Hernia, Abdominal |