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

NCT05805449 | Recruiting FDA Device

• 1 other identifier: HSC-MS-22-0759
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anal Fistula

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of participants who have post operative pain as assessed by the visual analog scale (VAS)

  14 days after surgery

• Change in fecal continence as assessed by the Cleveland Clinic Fecal Incontinence (CCFI) scoring tool

  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

  12 months after surgery

Study Arms (4)

Surgery

SHAM COMPARATOR

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

Surgery plus platelet-rich plasma (PRP)

EXPERIMENTAL

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

Surgery plus matrix

EXPERIMENTAL

Procedure: Surgery; Device: Matrix

Surgery plus PRP plus matrix material

EXPERIMENTAL

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

Interventions

Surgery PROCEDURE

Control patients will receive usual standard of care surgical repair of their complex fistula by LIFT or advancement flap technique without any biologic adjunct.

Surgery; Surgery plus PRP plus matrix material; Surgery plus matrix; Surgery plus platelet-rich plasma (PRP)

Platelet-rich plasma (PRP) OTHER

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.

Surgery plus PRP plus matrix material; Surgery plus platelet-rich plasma (PRP)

Matrix DEVICE

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.

Surgery plus PRP plus matrix material; Surgery plus matrix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCES: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Rectal Fistula

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey L Van Eps, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey L Van Eps, MD

CONTACT

713-486-4600; Jeffrey.L.VanEps@uth.tmc.edu

Angielyn Rivera

CONTACT

713-416-1350; Angielyn.R.Rivera@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 10, 2023
• Study Start: February 21, 2023
• Primary Completion: February 28, 2026
• Study Completion: March 31, 2026
• Last Updated: April 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)