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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Justus-Liebig-Universitat Giessen, Giessen, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)

Device

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

Other names: Surgisis Biodesign

Flap

Device

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

Primary outcomes

Healing Success

Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Collaborators

Cook Biotech Incorporated
Cook Ireland, Ltd.

Registry information

Acronym: Surgisis® AFP

Important dates

Study start: 2008
Primary completion: 2013
Study completion: 2013
First posted: Oct 17, 2007
Registry last updated: Dec 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed