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

Anal Fistula Clinical Trial

— Surgisis® AFP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545441
• Other study ID #: 07-006
• Status: Completed
• Phase: N/A
• First received: October 16, 2007
• Last updated: December 2, 2014
• Start date: June 2008
• Est. completion date: April 2013

Study information

• Verified date: December 2014
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Device:
• Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)
Surgical placement of the Surgisis AFP is performed under general anesthesia.
• Flap
Advancement flap surgery is performed; no anal fistula plug is placed

Locations

Country	Name	City	State
Germany	Krankenhaus Waldfriede	Berlin
Germany	Justus-Liebig-Universitat Giessen	Giessen
Germany	End-und Dickdarmzentrum Hannover	Hannover
Germany	Enddarmzentrum Mannheim	Mannheim
Germany	Caritas-Krankenhaus St. Joseph	Regensburg
Germany	St. Joseph Hospital	Wiesbaden

Sponsors (3)

Lead Sponsor	Collaborator
Cook	Cook Biotech Incorporated, Cook Ireland, Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing Success	Healing was defined as "closure of external opening with absence of abscess, drainage and pain."	12 months	Yes