Surgisis Anal Fistula Plug Study: An Experience in Saudi Arabia

A Single-center Single Arm Prospective Study Evaluating the Surgisis Biodesign Anal Fistula Plug

The Surgisis Anal Fistula Plug study is a clinical trial conducted in Saudi Arabia to study the safety and effectiveness of the Surgisis AFP Plug in the treatment of chronic anal fistulas.

Up to 30 patients will be treated with the Surgisis Anal Fistula Plug using a standardized surgical procedure to plug their anal fistula. Patients will be followed periodically until their 12-month follow-up.

Inclusion Criteria:

• 18 years old or older
• Primary, persistent, or recurrent fistula tract that is either transsphincteric, suprasphincteric, or extrasphincteric
• Signed informed consent
• Willing to return for follow-up visits

Exclusion Criteria:

• Crohn's Disease
• Ulcerative Colitis
• HIV Positive
• Immune System Disorder
• Collagen Disorder
• Tuberculosis
• History of radiation to anorectal region
• Allergies to pig tissue
• Religious or cultural objection to use of pig tissue in this surgical application
• J-pouch fistulas
• Previous Surgisis AFP Plug placement in target fistula tract
• Tracts with acute abscess, infection or inflammation
• Superficial fistula tracts conventionally treated with fistulotomy/fistulectomy