A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas

A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas

The purpose of this study is to determine whether the Surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap procedure.

Inclusion Criteria:

• Over eighteen years old
• Clinical diagnosis of primary anal fistula categorized as transsphincteric, suprasphincteric, or extrasphincteric in nature
• Pre-placement of seton required for at least 6 weeks prior to surgical treatment
• Willing to sign informed consent and share data with study sponsor and Surgisis AFP manufacturer

Exclusion Criteria:

• Recurrent fistula tracts
• J-pouch fistulas
• Superficial fistulas
• Fistulas with active abscess, infection, or acute inflammation
• History of Chron's Disease
• History of Ulcerative Colitis
• History of HIV or other immune system disease
• History of collagen disease
• History of radiation to the anorectal region
• Allergies to pig tissue or pig products
• Religious or cultural objection to the use of pig tissue