NCT01268514

ENHANCE: A Prospective EvaluatioN of Permacol™ in tHe Repair of Complex AbdomiNal Wall CasEs

ENHANCE: A Prospective Long-term EvaluatioN of the Use of Permacol™ Biological Implant in tHe Repair of Complex AbdomiNal Wall CasEs

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 115 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this prospective study is to evaluate short-term, mid-term, and long-term clinical outcomes associated with the use of Permacol™ Biological Implant in the treatment of complex abdominal wall defects

Detailed description

This will be a prospective, multi-centre, non-randomized study to collect post-market clinical data on Permacol™ Biological Implant following complex abdominal wall repair (including abdominal wall defects and fascial dehiscence). The subjects will have baseline and day of surgery visits performed, and then subjects will return to the investigator for evaluation of defect and safety related morbidities at follow up visits scheduled at 1 month, 6 months, 12 months, 24 months, and 36 months post-surgery. The study will enroll up to 200 subjects at up to 20 sites. Enrollment is anticipated to take between 18 and 24 months.

Conditions

• Hernia, Abdominal
• Abdominal Injuries

Timeline

• Start date: 2011-02-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2010-12-31
• Last updated: 2024-05-10
• Results posted: 2019-02-08

Locations

12 sites across 5 countries: Belgium, Germany, Italy, Luxembourg, United Kingdom