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

This study is currently recruiting participants.
Verified July 2012 by Cook
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: July 17, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Anal Fistula
 Device: Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)
Device: Flap

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas

Resource links provided by NLM:

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • Healing [ Time Frame: One Year ]

Secondary Outcome Measures:
  • Quality of Life, Continence, Complications [ Time Frame: One Year ]

Estimated Enrollment: 106
Study Start Date: June 2008
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545441

Contacts
Contact: Jason P. Hodde, MS 765-497-3355 hodde@cookbiotech.com

Locations
Germany
Krankenhaus Waldfriede Recruiting
Berlin, Germany
Contact: Dr. Roland Scherer     +4930/81810151     r.scherer@waldriede.de    
Justus-Liebig-Universitat Giessen Recruiting
Giessen, Germany, 35385
Contact: Thilo Schwandner, MD     +49-641-994-4200     t.schwandner@web.de    
End-und Dickdarmzentrum Hannover Recruiting
Hannover, Germany
Contact: Michael Roblick     +49 511 646 646-0     info@edh.de    
Enddarmzentrum Mannheim Recruiting
Mannheim, Germany
Contact: Prof. Dr. med. Alexander Herold     +49 621 1234 7570     alex@heroldhomeline.de    
Caritas-Krankenhaus St. Joseph Recruiting
Regensburg, Germany
Contact: Dr. Alois Fuerst     +49941/7823310     afuerst@caritasstjosef.de    
St. Joseph Hospital Recruiting
Wiesbaden, Germany
Contact: Dr. Ulrike Soetje     +49611/1771376     drulrikesoetje@web.de    
Sponsors and Collaborators
Cook
Cook Biotech Incorporated
Cook Ireland, Ltd.
Investigators
Principal Investigator: Thilo Schwandner, MD Justus-Liebig-Universitat Giessen
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00545441     History of Changes
Other Study ID Numbers: 07-006
Study First Received: October 16, 2007
Last Updated: July 17, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Cook:
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

ClinicalTrials.gov processed this record on October 17, 2012