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

Purpose

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

Condition

  • Anal Fistula

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Sham Comparator
Surgery 		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.
  • Procedure: Surgery
    Control patients will receive usual standard of care surgical repair of their complex fistula by LIFT or advancement flap technique without any biologic adjunct.
Experimental
Surgery plus platelet-rich plasma (PRP)
  • Procedure: Surgery
    Control patients will receive usual standard of care surgical repair of their complex fistula by LIFT or advancement flap technique without any biologic adjunct.
  • Other: Platelet-rich plasma (PRP)
    Participants will have 40-50cc of peripheral whole blood drawn into a syringe pre-loaded with acid citrate dextrose (ACD) anticoagulant and concentrated PRP harvested by double centrifugation technique using the manufacturer's kit and benchtop centrifuge. This typically yields 5-8cc of PRP that is 18-times more concentrated than baseline.
Experimental
Surgery plus matrix
  • Procedure: Surgery
    Control patients will receive usual standard of care surgical repair of their complex fistula by LIFT or advancement flap technique without any biologic adjunct.
  • Device: Matrix
    Participants will receive 200g of "paste" matrix and 200g injected at the following sites: the internal opening closure site at level of the sphincter muscle, within the walls of the fistula tract along its length, and within the tissue of an advancement flap particularly at areas of tissue apposition.
Experimental
Surgery plus PRP plus matrix material
  • Procedure: Surgery
    Control patients will receive usual standard of care surgical repair of their complex fistula by LIFT or advancement flap technique without any biologic adjunct.
  • Other: Platelet-rich plasma (PRP)
    Participants will have 40-50cc of peripheral whole blood drawn into a syringe pre-loaded with acid citrate dextrose (ACD) anticoagulant and concentrated PRP harvested by double centrifugation technique using the manufacturer's kit and benchtop centrifuge. This typically yields 5-8cc of PRP that is 18-times more concentrated than baseline.
  • Device: Matrix
    Participants will receive 200g of "paste" matrix and 200g injected at the following sites: the internal opening closure site at level of the sphincter muscle, within the walls of the fistula tract along its length, and within the tissue of an advancement flap particularly at areas of tissue apposition.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Jeffrey L Van Eps, MD
713-486-4600
Jeffrey.L.VanEps@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Jeffrey L Van Eps, MD
713-486-4600
Jeffrey.L.VanEps@uth.tmc.edu