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

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

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

Inclusion Criteria:

• complex cryptoglandular transsphincteric anal fistula undergoing surgical repair by LIFT 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 repair procedures/year

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 or pelvic/perineal radiation