Incisional Hernia, Ventral Hernia
Conditions
Brief summary
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.
Interventions
DEVICECook® Antimicrobial Hernia Repair Device
Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected
Sponsors
Cook Group Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient presents with a ventral or incisional hernia that is to be surgically corrected using open repair technique
Exclusion criteria
* Body Mass Index (BMI) \< 25. * Body weight \< 45 kg * Glycosylated Hemoglobin (Hgb A1c) \> 10% * Albumin \< 2.5 g/dL or pre-albumin \< 5.0 mg/dL * Renal insufficiency, as determined by an estimated glomerular filtration rate (GFR) \< 60 mL/min/1.73 m2 * Known allergies to study device components * Other relevant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Surgical Site Infection | 6 months |
Secondary
| Measure | 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 |
Countries
Canada, United Kingdom
Outcome results
None listed