NCT02401334

Antimicrobial Hernia Repair Device Clinical Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Cook Group Incorporated · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventral Hernia
• Incisional Hernia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-01-25
• Completion: 2018-01-25
• First posted: 2015-03-27
• Last updated: 2018-02-15

Locations

4 sites across 2 countries: Canada, United Kingdom