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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2013

Interventions

  • Device: Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)
    • Surgical placement of the Surgisis AFP is performed under general anesthesia.
  • Device: Flap
    • Advancement flap surgery is performed; no anal fistula plug is placed

Arms, Groups and Cohorts

  • Experimental: 1
    • Surgisis® AFP
  • Active Comparator: 2
    • Flap

Clinical Trial Outcome Measures

Primary Measures

  • Healing Success
    • Time Frame: 12 months
    • Healing was defined as “closure of external opening with absence of abscess, drainage and pain.”

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cook Group Incorporated
  • Collaborator
    • Cook Biotech Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Thilo Schwandner, MD, Principal Investigator, Justus-Liebig-Universitat Giessen

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