Antimicrobial Hernia Repair Device Clinical Study (AMEX)

February 14, 2018 updated by: Cook Group Incorporated

Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Queen Elizabeth II Health Sciences Centre
  • United Kingdom
      • Liverpool, United Kingdom, L7 8XP
        • Royal Liverpool Hospital
    • England
      • Salford, England, United Kingdom, M68HD
        • Salford Royal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hernia Repair
Surgical repair for hernia with implantation of the Cook® Antimicrobial Hernia Repair Device.
Device: Cook® 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Surgical Site Infection
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome 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).
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

January 25, 2018

Study Completion (Actual)

January 25, 2018

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Actual)

February 15, 2018

Last Update Submitted That Met QC Criteria

February 14, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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