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Antimicrobial Hernia Repair Device Clinical Study (AMEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02401334
Recruitment Status : Completed
First Posted : March 27, 2015
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ventral Hernia Incisional Hernia Device: Cook® Antimicrobial Hernia Repair Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia
Study Start Date : June 2015
Actual Primary Completion Date : January 25, 2018
Actual Study Completion Date : January 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Hernia

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




Primary Outcome Measures :
  1. Incidence of Surgical Site Infection [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401334


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

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Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT02401334     History of Changes
Other Study ID Numbers: 13-10
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Incisional Hernia
Pathological Conditions, Anatomical
Hernia, Abdominal
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents