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

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

Study Overview

• Status: Recruiting
• Conditions: Anal Fistula
• Intervention / Treatment: Procedure: Surgery; Other: Platelet-rich plasma (PRP); Device: Matrix

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeffrey L Van Eps, MD; Phone Number: 713-486-4600; Email: Jeffrey.L.VanEps@uth.tmc.edu
• Study Contact Backup: Name: Angielyn Rivera; Phone Number: 713-416-1350; Email: Angielyn.R.Rivera@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Jeffrey L Van Eps, MD; Phone Number: 713-486-4600; Email: Jeffrey.L.VanEps@uth.tmc.edu
      • Contact: Angielyn Rivera; Phone Number: 713-416-1350; Email: Angielyn.R.Rivera@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with fistula recurrence	A fistula recurrence is defined as one or more of the following clinical signs or symptoms after repair: recurrent abscess at the site of repair, chronic drainage or passage of flatus from an external opening of the perineum away from the anal verge, a non-healing external opening that tracks toward anus by probing with fistula probe.	upto 6 months after surgery
Change in Health-related quality of life (HRQoL) as assessed by the EQ-5D-5L questionnaire	This instrument queries subjects on health status related to mobility, self-care, 'usual' activities, pain/discomfort, and anxiety/depression with 5 potential responses ranging from "no problems" to inability to complete the task or extreme levels of pain/depression, correlating to a discrete index score from 1-5, a higher number indicating a worse outcome.The instrument also includes an overall VAS self-rating of health ranging from 0-100, higher number indicating better health.	Baseline, 1week post surgery, 2 weeks post surgery, 6 weeks post surgery, 3 months post surgery, 6 months post surgery, and 12 months post surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who have post operative pain as assessed by the visual analog scale (VAS)	This is scored from 0-100, higher number indicating better health	14 days after surgery
Change in fecal continence as assessed by the Cleveland Clinic Fecal Incontinence (CCFI) scoring tool	This is a 5 item questionnaire that assesses type of incontinence (solid, liquid, gas, wears pad, lifestyle alteration). The frequency with which each type of incontinence occurs is rated on a scale from 0 (never) to 4 (always or to 1/day). The sum of the frequencies is added to yield a total score that can range from 0 to 20, with higher scores indicating higher levels of incontinence.	Baseline, 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery and 12 months after surgery
The relative cost utility of the different treatment strategies as assessed by a questionnaire	A cost effectiveness analysis (CEA) will be done from the healthcare system perspective assessed as the incremental health system costs (or savings) per fistula recurrence prevented	12 months after surgery

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCES
• Investigators: Principal Investigator: Jeffrey L Van Eps, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Anticipated): February 28, 2026
• Study Completion (Anticipated): March 31, 2026

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: HSC-MS-22-0759

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No