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:
Cook
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
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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:
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
Keywords provided by Cook:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
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