Parastomal Reinforcement With Strattice

A Prospective, Multicenter, Randomized, Controlled, Third-party Blinded Study of Strattice Fascial Inlay for Parastomal Reinforcement in Patients Undergoing Surgery for Permanent Abdominal Wall Ostomies

The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of parastomal hernia.

Inclusion Criteria:

• adults
• need for permanent ileostomy or colostomy

Exclusion Criteria:

• history of hernia at new ostomy site
• has previously implanted surgical mesh at site of planned ostomy
• requires a temporary ostomy
• has need for multiple ostomies
• is receiving chronic immunosuppression therapy, has MELD score of > 17, has severe COPD, systemic infection, or known collagen disorder
• is bedridden or otherwise non-ambulatory