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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00545441
Recruitment Status : Completed
First Posted : October 17, 2007
Results First Posted : October 29, 2014
Last Update Posted : December 17, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Anal Fistula Device: Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP) Device: Flap

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas
Study Start Date : June 2008
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Surgisis® AFP
Device: Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)
Surgical placement of the Surgisis AFP is performed under general anesthesia.
Other Name: Surgisis Biodesign
Active Comparator: 2
Device: Flap
Advancement flap surgery is performed; no anal fistula plug is placed

Outcome Measures

Primary Outcome Measures :
  1. Healing Success [ Time Frame: 12 months ]
    Healing was defined as "closure of external opening with absence of abscess, drainage and pain."

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545441

Krankenhaus Waldfriede
Berlin, Germany
Justus-Liebig-Universitat Giessen
Giessen, Germany, 35385
End-und Dickdarmzentrum Hannover
Hannover, Germany
Enddarmzentrum Mannheim
Mannheim, Germany
Caritas-Krankenhaus St. Joseph
Regensburg, Germany
St. Joseph Hospital
Wiesbaden, Germany
Sponsors and Collaborators
Cook Group Incorporated
Cook Biotech Incorporated
Cook Ireland, Ltd.
Principal Investigator: Thilo Schwandner, MD Justus-Liebig-Universitat Giessen
More Information

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT00545441     History of Changes
Other Study ID Numbers: 07-006
First Posted: October 17, 2007    Key Record Dates
Results First Posted: October 29, 2014
Last Update Posted: December 17, 2014
Last Verified: December 2014

Keywords provided by Cook Group Incorporated:
Anal fistula
fistula in ano
anorectal fistula

Additional relevant MeSH terms:
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases