Antimicrobial Hernia Repair Device Clinical Study (AMEX)

Cook Group

Status: Completed

Conditions: Incisional Hernia; Ventral Hernia

Treatments: Device: Cook® Antimicrobial Hernia Repair Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02401334

13-10

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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 exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Hernia Repair

Experimental group

Description:

Surgical repair for hernia with implantation of the Cook® Antimicrobial Hernia Repair Device.

Treatment:

Device: Cook® Antimicrobial Hernia Repair Device