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

Launched by ALEXANDER HAWKINS · Oct 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for complex perianal fistulas, which are abnormal connections between the rectum and the skin that can be quite challenging to heal. The trial is testing a special collagen plug enhanced with a substance called RhPDGF-BB, which is known to help with wound healing. The goal is to see if this new treatment can improve healing rates and reduce the chances of the fistula reopening, compared to standard surgical options.

To participate in the trial, individuals must be over 21 years old and have a single perianal fistula that cannot be treated with traditional surgery. They should currently have a draining seton (a type of medical device) in place. Participants need to be willing to follow the study's guidelines and attend follow-up appointments. Throughout the trial, participants will receive close monitoring and support as they undergo this new treatment. It’s important to note that not everyone can join; there are specific medical conditions and recent surgeries that may disqualify someone from participation.

Gender

ALL

Eligibility criteria

• 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 branching fistula tract to a single tract is not exclusionary), \>1 internal opening, moderate or severe proctitis, severe rectal mucosal fibrosis surrounding the internal opening preventing the securing of the fistula plug disk, any anatomical limitation to successfully securing the fistula plug disk.
• • Known allergic reactions to porcine collagen or yeast-derived products
• • Currently enrolled in a drug or device trial or within 30 days of last investigational drug or device administration at baseline visit where investigational treatment (drug or device) was placed in or near the fistula tract or may potentially interact with study treatment
• • Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
• • Active infection at the application site
• • The presence of malignant neoplasms at the application site
• • Prior radiation therapy at the application site