BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma

Last updated: April 5, 2023
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rectal Disorders

Treatment

N/A

Clinical Study ID

NCT05805449
HSC-MS-22-0759
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to compare the clinical effectiveness of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix (UBM) to usual surgical care alone to prevent fistula recurrence or improve HRQoL, to compare the effects of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix on early postoperative pain and fecal continence and to assess the cost utility of augmented complex fistula repair relative to usual surgical care

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • complex cryptoglandular transsphincteric anal fistula undergoing surgical repair byLIFT or advancement flap procedure
  • English or Spanish speaking and capable of providing informed consent
  • Willing to undergo temporary anal seton drainage for requisite time prior to repair
  • Participating surgeons will only be eligible if they perform at least 3 repairprocedures/year

Exclusion

Exclusion Criteria:

  • Unable to reliably complete follow up for 12 months postoperatively
  • Primary platelet disorders
  • Thrombocytopenia < 150 plt/microliter
  • Inability to stop anti-platelet agent > 5 days preoperatively
  • Fistula associated with inflammatory bowel disease (IBD), malignancy orpelvic/perineal radiation

Study Design

Total Participants: 250
Study Start date:
February 21, 2023
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.