Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor decision to discontinue the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This prospective early feasibility clinical study will collect information regarding the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated and contaminated (i.e., Class II and Class III) surgical fields.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antimicrobial Hernia Repair Device | Experimental | Antimicrobial hernia repair device for repair of ventral or incisional hernias in Class II and III surgical fields. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antimicrobial Hernia Repair Device | Device | hernia repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients that develop a surgical site infection | Surgical site infections (SSI) that will be included in this outcome measure are deep incisional, organ/space, and superficial incisional. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hernia recurrences | Hernia recurrences is the protrusion of abdominal tissue through a defect in the abdominal wall at the site of the hernia repaired during the index procedure. | 24 months |
| Frequency of procedural and post-operative adverse events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The adverse events will be bowel erosion, bowl obstruction, delayed wound infection, fever, fistula formation, graft contraction, hernia recurrence, ileus, need for revision/resurgery, pain, premature degradation, wound dehiscence, and other wound complications. |
| 24 months |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |