Eligibility

Ages Eligible for Study

18 years and up

Genders Eligible for Study

Both

Keywords

Complex, Abdominal Wall Reconstruction, AWR, and Hernia

Sponsors

Industry

Covidien

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

Detailed Description

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