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

Primary Purpose

Anal Fistula

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surgery
Platelet-rich plasma (PRP)
Matrix
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Experimental

Experimental

Experimental

Arm Label

Surgery

Surgery plus platelet-rich plasma (PRP)

Surgery plus matrix

Surgery plus PRP plus matrix material

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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.
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

Full Information

First Posted
March 16, 2023
Last Updated
April 5, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCES
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1. Study Identification

Unique Protocol Identification Number
NCT05805449
Brief Title
BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma
Acronym
BIO RAMP
Official Title
The BIO RAMP Trial - BIOlogic Augmented Repair of Complex Anal Fistula Using Acellular Matrix and/or Autologous Platelet-rich Plasma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCES

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgery
Arm Type
Sham Comparator
Arm 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.
Arm Title
Surgery plus platelet-rich plasma (PRP)
Arm Type
Experimental
Arm Title
Surgery plus matrix
Arm Type
Experimental
Arm Title
Surgery plus PRP plus matrix material
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Control patients will receive usual standard of care surgical repair of their complex fistula by LIFT or advancement flap technique without any biologic adjunct.
Intervention Type
Other
Intervention Name(s)
Platelet-rich plasma (PRP)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Matrix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with fistula recurrence
Description
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.
Time Frame
upto 6 months after surgery
Title
Change in Health-related quality of life (HRQoL) as assessed by the EQ-5D-5L questionnaire
Description
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.
Time Frame
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 Measure Information:
Title
Number of participants who have post operative pain as assessed by the visual analog scale (VAS)
Description
This is scored from 0-100, higher number indicating better health
Time Frame
14 days after surgery
Title
Change in fecal continence as assessed by the Cleveland Clinic Fecal Incontinence (CCFI) scoring tool
Description
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.
Time Frame
Baseline, 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery and 12 months after surgery
Title
The relative cost utility of the different treatment strategies as assessed by a questionnaire
Description
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
Time Frame
12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey L Van Eps, MD
Phone
713-486-4600
Email
Jeffrey.L.VanEps@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Angielyn Rivera
Phone
713-416-1350
Email
Angielyn.R.Rivera@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey L Van Eps, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey L Van Eps, MD
Phone
713-486-4600
Email
Jeffrey.L.VanEps@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Angielyn Rivera
Phone
713-416-1350
Email
Angielyn.R.Rivera@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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