Retrospective Review of the Cook Biodesign® Fistula Plug to Treat Anorectal Fistulas

Cook Group Incorporated79 enrolled

Overview

The study is a retrospective review of the use of the Biodesign® Fistula Plug (C-FPS-\[X\]). A total of 73 patients will be enrolled who have had a fistula plug placed to treat anorectal fistulas and will therefore be eligible for statistical analysis.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Anorectal Fistula

Interventions

Cook Biodesign® Fistula PlugDEVICE

The Cook Biodesign® Fistula Plug is for implantation to reinforce soft tissue for repair of Anorectal fistulas.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who have had surgery to treat anorectal fistula where the Biodesign® Fistula Plug was placed during the procedure Exclusion Criteria: * Patients not receiving the Biodesign® Fistula Plug for treatment of their anorectal fistula

Locations (4)

University of Louisville School of Medicine

Louisville, Kentucky, United States

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, United States

University Surgical Associates

Providence, Rhode Island, United States

St Josef's Hospital

Wiesbaden, Germany

Outcomes

Primary Outcomes

Rate of fistula closure

Absence of drainage from the external fistula opening with complete epithelialization of the external fistula opening upon clinical exam.

Time frame: up to 2 years

Data from ClinicalTrials.gov

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