Antimicrobial Hernia Repair Device Clinical Study

Not Applicable

Completed

• Conditions: Ventral Hernia; Incisional Hernia
• Interventions: Device: Cook® Antimicrobial Hernia Repair Device

• Registration Number: NCT02401334
• Lead Sponsor: Cook Group Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-27
• Study Start: 2015-06
• Primary Completion: 2018-01-25
• Study Completion: 2018-01-25
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-14
• Last Update Posted: 2018-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of Surgical Site Infection	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

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