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

Primary Purpose

Anal Fistula

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)
Flap
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Fistula focused on measuring Anal fistula, fistula in ano, anorectal fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Krankenhaus Waldfriede
  • Justus-Liebig-Universitat Giessen
  • End-und Dickdarmzentrum Hannover
  • Enddarmzentrum Mannheim
  • Caritas-Krankenhaus St. Joseph
  • St. Joseph Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Surgisis® AFP

Flap

Outcomes

Primary Outcome Measures

Healing Success
Healing was defined as "closure of external opening with absence of abscess, drainage and pain."

Secondary Outcome Measures

Full Information

First Posted
October 16, 2007
Last Updated
December 2, 2014
Sponsor
Cook Group Incorporated
Collaborators
Cook Biotech Incorporated, Cook Ireland, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00545441
Brief Title
A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas
Acronym
Surgisis® AFP
Official Title
A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated
Collaborators
Cook Biotech Incorporated, Cook Ireland, Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula
Keywords
Anal fistula, fistula in ano, anorectal fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Surgisis® AFP
Arm Title
2
Arm Type
Active Comparator
Arm Description
Flap
Intervention Type
Device
Intervention Name(s)
Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)
Other Intervention Name(s)
Surgisis Biodesign
Intervention Description
Surgical placement of the Surgisis AFP is performed under general anesthesia.
Intervention Type
Device
Intervention Name(s)
Flap
Intervention Description
Advancement flap surgery is performed; no anal fistula plug is placed
Primary Outcome Measure Information:
Title
Healing Success
Description
Healing was defined as "closure of external opening with absence of abscess, drainage and pain."
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thilo Schwandner, MD
Organizational Affiliation
Justus-Liebig-Universitat Giessen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krankenhaus Waldfriede
City
Berlin
Country
Germany
Facility Name
Justus-Liebig-Universitat Giessen
City
Giessen
ZIP/Postal Code
35385
Country
Germany
Facility Name
End-und Dickdarmzentrum Hannover
City
Hannover
Country
Germany
Facility Name
Enddarmzentrum Mannheim
City
Mannheim
Country
Germany
Facility Name
Caritas-Krankenhaus St. Joseph
City
Regensburg
Country
Germany
Facility Name
St. Joseph Hospital
City
Wiesbaden
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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