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

Cook Group

Status: Completed

Conditions: Anal Fistula

Treatments: Device: Flap; Device: Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545441

07-006

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

1

Experimental group

Description:

Surgisis® AFP

Treatment:

Device: Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)

2

Active Comparator group

Description:

Flap

Treatment:

Device: Flap