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

NCT00545441 | Completed Results

• 1 other identifier: 07-006
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 6

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.

Conditions

Anal Fistula

Keywords

Anal fistula; fistula in ano; anorectal fistula

Outcome Measures

Primary Outcomes (1)

• Healing Success

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

  12 months

Study Arms (2)

1

EXPERIMENTAL

Surgisis® AFP

Device: Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)

2

ACTIVE COMPARATOR

Flap

Device: Flap

Interventions

Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP) DEVICE

Surgical placement of the Surgisis AFP is performed under general anesthesia.

Also known as: Surgisis Biodesign

1

Flap DEVICE

Advancement flap surgery is performed; no anal fistula plug is placed

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cook Group Incorporated: lead
• Cook Biotech Incorporated: collaborator
• Cook Ireland, Ltd.: collaborator

Study Sites (6)

Justus-Liebig-Universitat Giessen

Giessen, Giessen, 35385, Germany

Location

Krankenhaus Waldfriede

Berlin, Germany

Location

End-und Dickdarmzentrum Hannover

Hanover, Germany

Location

Enddarmzentrum Mannheim

Mannheim, Germany

Location

Caritas-Krankenhaus St. Joseph

Regensburg, Germany

Location

St. Joseph Hospital

Wiesbaden, Germany

Location

MeSH Terms

Conditions

Rectal Fistula

Interventions

Surgical Flaps

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgically-Created Structures; Equipment and Supplies

Results Point of Contact

• Title: Jason Hodde, Clinical Affairs Manager
• Organization: Cook Biotech Incorporated

jhodde@cookbiotech.com

765-497-3355

Study Officials

• Thilo Schwandner, MD

  Justus-Liebig-Universitat Giessen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 17, 2007
• Study Start: June 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 17, 2014
• Results First Posted: October 29, 2014

Record last verified: 2014-12

Locations

DE (6)