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

Medtronic

Status: Completed

Conditions: Abdominal Injuries; Hernia, Abdominal

Study type: Observational

Funder types: Industry

Identifiers

NCT01268514

COVPERH0108

Details and patient eligibility

About

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

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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