ENHANCE: A Prospective EvaluatioN of Permacol™ in tHe Repair of Complex AbdomiNal Wall CasEs
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
|Study Design:||Time Perspective: Prospective|
|Official Title:||ENHANCE: A Prospective Long-term EvaluatioN of the Use of Permacol™ Biological Implant in tHe Repair of Complex AbdomiNal Wall CasEs|
- Hernia Recurrence [ Time Frame: 36 months ] [ Designated as safety issue: No ]o Characterize longitudinal outcomes at 36 months post-surgery of the proportion of subjects who undergo reoperation for hernia or hernia recurrence.
- Short-term and mid-term outcomes [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- 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
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
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.
|AZ St.-Jan AV|
|AZ St Lucas|
|CHU Ambroise Paré|
|Universitätsklinikum des Saarlandes|
|Homburg, Germany, 66424|
|RCCS Istituto Clinico Humanitas di Milano|
|Istituto Nazionale Tumori|
|University Hospital (C/O Istituto Clinica Chirugica II)|
|Centre Hospitalier Emile Mayrisch|
|Esch Sur Alzette, Luxembourg, 4005|
|Whipps Cross University Hospital|
|Leytonstone, London, United Kingdom, E11 1NR|
|Royal Devon and Exeter Hospital|
|Exeter, Wonford, United Kingdom, EX2 5DW|
|Royal Victoria Infirmary|
|Newcastle Upon Tyne, United Kingdom, NE1 4LP|
|Torquay, United Kingdom, TQ2 7AA|
|Principal Investigator:||Pasquale Giordano, MD||Whipps Cross University Hospital|