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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

Brief 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 Summary:

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.


Sponsor: Medtronic - MITG

Current Primary Outcome: Hernia Recurrence [ Time Frame: 36 months ]

o Characterize longitudinal outcomes at 36 months post-surgery of the proportion of subjects who undergo reoperation for hernia or hernia recurrence.


Original Primary Outcome: Same as current

Current Secondary Outcome: Short-term and mid-term outcomes [ Time Frame: 24 months ]

  • Characterize short-term and mid-term outcomes within 24 months post-surgery of the proportion of subjects who undergo reoperation for hernia or hernia recurrence.
  • QOL by Carolinas Comfort Scale
  • Patient Satisfaction Questionnaire
  • Subjects incidence of post-operative complications


Original Secondary Outcome: Same as current

Information By: Medtronic - MITG

Dates:
Date Received: December 29, 2010
Date Started: February 2011
Date Completion: April 2017
Last Updated: February 13, 2017
Last Verified: February 2017