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

Medtronic - MITG115 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

115

Conditions

Hernia, Abdominal Abdominal Injuries

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Subjects who meet all of the following criteria will be eligible for study enrollment: 1. Subjects who are 18 years of age and older 2. Subjects of either sex 3. Subjects who require complex abdominal repair using Permacol™ Biological Implant. 4. 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: 1. Subjects who are pregnant 2. 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 3. Subjects may not participate in any other clinical study that clinically interferes with this study while enrolled 4. Concomitant use of a synthetic or another biologic mesh 5. Subjects who require use of Permacol™ as only temporary closure with planned reoperation, or Permacol™ used as a temporary dressing in an open abdomen 6. Subject who has systemic sepsis at the time of Permacol™ implantation 7. Subject with ongoing necrotizing pancreatitis 8. Subject who requires use of Permacol™ in parastomal hernia repair alone, where there is no other anterior wall repair 9. Subject who requires prophylactic use of Permacol™ in the formation of stoma with anterior wall repair 10. Permacol™ used in pelvic floor reconstruction

Locations (12)

AZ St Lucas

Ghent, Belgium

CHU Ambroise Pare

Mons, Belgium

CHU Ambroise Paré

Mons, Belgium

Outcomes

Primary Outcomes

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.

Time frame: 36 months post-surgery

Secondary Outcomes

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.

Time frame: 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

Time frame: 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?

Time frame: 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?

Data from ClinicalTrials.gov

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