Antimicrobial Hernia Repair Device Clinical Study 13-10

• Research type

  Research Study

• Full title

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

• IRAS ID

  160162

• Contact name

  Maja Skytte

• Contact email

  maja.skytte@cookmedical.com

• Sponsor organisation

  William Cook Europe

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  The development of the Cook® Antimicrobial Hernia Repair Device was undertaken to prevent hernia graft failure from bacterial colonization and infection when placed in contaminated settings. This clinical study is being performed with this context in mind. This prospective clinical study will evaluate the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device containing gentamicin to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated or contaminated surgical fields. Up to 30 patients will be treated with the Cook® Antimicrobial Hernia Repair Device and patients will be followed for 6 months.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  14/NW/1474

• Date of REC Opinion

  19 Dec 2014

• REC opinion

  Favourable Opinion