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

The University of Texas System (UT)

Status: Enrolling

Conditions: Anal Fistula

Treatments: Other: Platelet-rich plasma (PRP); Device: Matrix; Procedure: Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05805449

HSC-MS-22-0759

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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250 participants in 4 patient groups

Surgery

Sham Comparator group

Description:

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.

Treatment:

Procedure: Surgery

Surgery plus platelet-rich plasma (PRP)

Experimental group

Treatment:

Other: Platelet-rich plasma (PRP)

Procedure: Surgery

Surgery plus matrix

Experimental group

Treatment:

Device: Matrix

Procedure: Surgery

Surgery plus PRP plus matrix material

Experimental group

Treatment:

Device: Matrix

Other: Platelet-rich plasma (PRP)

Procedure: Surgery