NCT00545441CompletedNot Applicable
A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cook Group Incorporated
- Enrollment
- 86
- Locations
- 6
- Primary Endpoint
- Healing Success
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Experimental
Surgisis® AFP
Intervention: Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP) (Device)
2
Active Comparator
Flap
Intervention: Flap (Device)
Outcomes
Primary Outcomes
Healing Success
Time Frame: 12 months
Healing was defined as "closure of external opening with absence of abscess, drainage and pain."
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (6)
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