BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma (BIO RAMP)
Anal Fistula
About this trial
This is an interventional treatment trial for Anal Fistula
Eligibility Criteria
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
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Sham Comparator
Experimental
Experimental
Experimental
Surgery
Surgery plus platelet-rich plasma (PRP)
Surgery plus matrix
Surgery plus PRP plus matrix material
Control patients will receive usual standard of care surgical repair of their complex fistula by The ligation of intersphincteric tract (LIFT) or advancement flap technique without any biologic adjunct.