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

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ClinicalTrials.gov Identifier: NCT00545441
Recruitment Status : Completed
First Posted : October 17, 2007
Results First Posted : October 29, 2014
Last Update Posted : December 17, 2014
Sponsor:
Collaborators:
Cook Biotech Incorporated
Cook Ireland, Ltd.
Information provided by (Responsible Party):
Cook Group Incorporated

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 Phase
Anal Fistula Device: Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP) Device: Flap Not Applicable

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
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

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
Flap
Device: Flap
Advancement flap surgery is performed; no anal fistula plug is placed




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."



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

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

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


Locations
Germany
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.
Investigators
Principal Investigator: Thilo Schwandner, MD Justus-Liebig-Universitat Giessen

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:
Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases