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This prospective clinical study will evaluate the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected (i.e., Class II, Class III, and Class IV) surgical fields. Up to 30 patients will be treated with the Cook® Antimicrobial Hernia Repair Device and patients will be followed for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hernia Repair | Experimental | Surgical repair for hernia with implantation of the Cook® Antimicrobial Hernia Repair Device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cook® Antimicrobial Hernia Repair Device | Device | Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Surgical Site Infection | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of procedural or post-operative adverse events related to the study device or procedure (i.e., Permanence of hernia repair, as determined by hernia recurrence). | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada | ||
| Queen Elizabeth II Health Sciences Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32228664 | Derived | Minor S, Brown CJ, Rooney PS, Hodde JP, Julien L, Scott TM, Karimuddin AA, Raval MJ, Phang PT. Single-stage repair of contaminated hernias using a novel antibiotic-impregnated biologic porcine submucosa tissue matrix. BMC Surg. 2020 Mar 30;20(1):58. doi: 10.1186/s12893-020-00715-w. |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Halifax |
| Nova Scotia |
| B3H 2Y9 |
| Canada |
| Salford Royal Hospital | Salford | England | M68HD | United Kingdom |
| Royal Liverpool Hospital | Liverpool | L7 8XP | United Kingdom |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |