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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hernia, Abdominal, Abdominal Injuries

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who meet all of the following criteria will be eligible for study enrollment: Subjects who are 18 years of age and older Subjects of either sex Subjects who require complex abdominal repair using Permacol™ Biological Implant. Subjects who are willing and able to adhere to protocol requirements and provide written informed consent Exclusion Criteria: All subjects who meet any of the following criteria should not be enrolled into the study: Subjects who are pregnant Subjects with a medical condition that in the opinion of the investigator may preclude participation (e.g. Ehlers Danlos Syndrome) or interfere with completion of study follow-up Subjects may not participate in any other clinical study that clinically interferes with this study while enrolled Concomitant use of a synthetic or another biologic mesh Subjects who require use of Permacol™ as only temporary closure with planned reoperation, or Permacol™ used as a temporary dressing in an open abdomen Subject who has systemic sepsis at the time of Permacol™ implantation Subject with ongoing necrotizing pancreatitis Subject who requires use of Permacol™ in parastomal hernia repair alone, where there is no other anterior wall repair Subject who requires prophylactic use of Permacol™ in the formation of stoma with anterior wall repair Permacol™ used in pelvic floor reconstruction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery | Characterize longitudinal outcomes at 36 months post-surgery of the proportion of subjects who undergo reoperation for hernia or hernia recurrence. | 36 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence | 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. | 24 months post-surgery | 
| QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. | Quality of Life by Carolina's Comfort Scale at 6 months, 12 months, 24 months, and 36 months. The areas of assessment were: Sensation of Mesh, Pain, and Movement Limitations at each of the follow-up time points. Unscheduled surgery is any surgery that is performed outside of the primary study procedure. The scale measurements: 0 = no symptoms; 1 = mild but not bothersome symptoms; 2 = mild and bothersome symptoms; 3 = moderate and/or daily symptoms,;4 = severe symptoms; 5 = disabling symptoms | 6, 12, 24 and 36 months post-surgery. We excluded patients who were not included in this assessment at the various time-points. | 
| Patient Satisfaction Questionnaire - Right Choice to Have Surgery | Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months. Question: Was it the right choice to have the surgery? | 6, 12, 24 and 36 months post-surgery | 
| Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months. Question: How satisfied are you with the outcome of the operation? | 6, 12, 24 and 36 months post-surgery | 
| Number of Participants With Post-op Complications | Subject incidence of post-operative complications, specifically: wound infection, seroma, hematoma, wound dehiscence, and fistula. Unscheduled surgery is any surgery that is performed outside of the primary study procedure. | 6, 12, 24 and 36 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complex, Abdominal Wall Reconstruction, AWR, Hernia