A Prospective Long-term Evaluation of the Use of Permacol™ Biological Implant in the Repair of Complex Abdominal Wall Cases

Study Objective

To collect short-term, mid-term and long term post-surgical data on Permacol™ Biological Implant following complex abdominal wall repair.

Participation conditions

Inclusion criteria

• Subjects who are 18 years of age and older
• Subjects of either sex
• Subjects who require complex abdominal repair using Permacol™ Biological Implant. Complex repair is defined as infected, contaminated, clean contaminated or clean with a history of infected or contaminated field, atypical hernia location, loss of domain, fascial dehiscence, and/or requiring abdominal wall mobilization for wound closure
• Subjects who are willing and able to adhere to protocol requirements and provide written informed consent

Exclusion criteria
 

• 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
• Subjects who has severe systemic sepsis at the time of Permacol™ implantation. Severe sepsis is defined as sepsis with organ dysfunction, hypoperfusion, or hypotension
• Subjects with ongoing necrotizing pancreatitis
• Subjects who requires use of Permacol™ in parastomal hernia alone, where there is no other anterior wall repair
• Subjects who requires prophylactic use of Permacol™ in the formation of stoma with anterior wall repair
• Permacol™ used in pelvic floor reconstruction
 

Centre Hospitalier Emile Mayrisch – Esch / Alzette