Evaluating an rhPDGF-BB-enhanced Collagen Plug for Perianal Fistula Healing

Inclusion Criteria: * Diagnosis of a single tract perianal fistula not amenable to fistulotomy as determined by the supervising surgeon * Fistula must currently have a draining seton in place * Aged \>21 years old * Willing and able to provide informed consent and to comply with study protocol and follow-up * Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: * Medical conditions that would, in the opinion of the investigator or treating provider, compromise the safety of the individual with study participation and/or the ability of the individual to follow study protocol * Genito-urinary fistulization, including rectovaginal (i.e., fistulas that transverse the vaginal canal) * Presence of an ileal anal pouch * Any major surgery of the gastrointestinal tract (including one or more segments of the colon or terminal ileum) within 3 months prior to randomization; presence of stoma is not exclusionary * Prior surgical procedure (i.e., Ligation of Intersphincteric Fistula Tract or Endorectal Advancement Flap) for the target fistula or a perianal procedure that resulted in a large soft tissue defect within 6 months prior to screening visit * One or more of the following fistula types or anatomic presentations: horseshoe fistulas, fistulas that do not have an opening inside the anal canal or low rectum, blind ending sinus tracts (no external opening), branching fistulas (a previously performed conversion of a …