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

Hernia, Abdominal Clinical Trial

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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01268514
Study type Observational
Source Medtronic - MITG
Contact
Status Completed
Phase
Start date February 2011
Completion date November 2016
View Details
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