Antimicrobial Hernia Repair Device Clinical Study

Cook Group Incorporated24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ventral Hernia Incisional Hernia

Interventions

Cook® Antimicrobial Hernia Repair DeviceDEVICE

Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (4)

St. Paul's Hospital

Vancouver, British Columbia, Canada

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Salford Royal Hospital

Salford, England, United Kingdom

Royal Liverpool Hospital

Liverpool, United Kingdom

Outcomes

Primary Outcomes

Incidence of Surgical Site Infection

Time frame: 6 months

Secondary Outcomes

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).

Time frame: 12 months

Data from ClinicalTrials.gov

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