N/A N=86 Randomized Treatment

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

Anal Fistula

Bottom Line

View on ClinicalTrials.gov: NCT00545441 ↗

Enrolled (actual)

Serious AEs

3.7%

Results posted

Oct 2014

Primary outcome: Primary: Healing Success — 22; 25 participants — p=0.59

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP) (Device); Flap (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cook Group Incorporated
Primary completion: Apr 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Healing Success	22; 25	0.59

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00545441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.