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

This study has been completed.
Sponsor:
Collaborators:
Cook Biotech Incorporated
Cook Ireland, Ltd.
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00545441
First received: October 16, 2007
Last updated: October 24, 2014
Last verified: June 2013

October 16, 2007
October 24, 2014
June 2008
April 2013   (final data collection date for primary outcome measure)
Healing Success [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Healing was defined as "closure of external opening with absence of abscess, drainage and pain."
Healing [ Time Frame: One Year ]
Complete list of historical versions of study NCT00545441 on ClinicalTrials.gov Archive Site
Not Provided
Quality of Life, Continence, Complications [ Time Frame: One Year ]
Not Provided
Not Provided
 
A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas
A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anal Fistula
  • Device: Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)
    Surgical placement of the Surgisis AFP is performed under general anesthesia.
    Other Name: Surgisis Biodesign
  • Device: Flap
    Advancement flap surgery is performed; no anal fistula plug is placed
  • Experimental: 1
    Surgisis® AFP
    Intervention: Device: Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)
  • Active Comparator: 2
    Flap
    Intervention: Device: Flap
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00545441
07-006
No
Cook
Cook
  • Cook Biotech Incorporated
  • Cook Ireland, Ltd.
Principal Investigator: Thilo Schwandner, MD Justus-Liebig-Universitat Giessen
Cook
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP