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OpenTrials
Completed

NCT Number: NCT02401334

Antimicrobial Hernia Repair Device Clinical Study

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.

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Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Incisional Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Paul's Hospital, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cook® Antimicrobial Hernia Repair Device

Device

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

Primary outcomes

  1. Incidence of Surgical Site Infection

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

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

Acronym: AMEX

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 27, 2015
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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