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

December 2, 2014 updated by: Cook Group Incorporated
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Krankenhaus Waldfriede
      • Giessen, Germany, 35385
        • Justus-Liebig-Universität Gießen
      • Hannover, Germany
        • End-und Dickdarmzentrum Hannover
      • Mannheim, Germany
        • Enddarmzentrum Mannheim
      • Regensburg, Germany
        • Caritas-Krankenhaus St. Joseph
      • Wiesbaden, Germany
        • St. Joseph Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Surgisis Biodesign
Active Comparator: 2
Flap
Device: Flap
Advancement flap surgery is performed; no anal fistula plug is placed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing Success
Time Frame: 12 months
Healing was defined as "closure of external opening with absence of abscess, drainage and pain."
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Collaborators

Cook Ireland, Ltd.
Cook Biotech Incorporated

Investigators

  • Principal Investigator: Thilo Schwandner, MD, Justus-Liebig-Universität Gießen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

October 16, 2007

First Submitted That Met QC Criteria

October 16, 2007

First Posted (Estimate)

October 17, 2007

Study Record Updates

Last Update Posted (Estimate)

December 17, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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