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Biologic Augmented Repair for Anal Fistulas (BIO RAMP Trial)
N/A
Recruiting
Led By Jeffrey L Van Eps, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Summary
This trial is testing whether adding PRP and UBM to surgery can better treat complex anal fistulas compared to surgery alone. PRP uses the patient's own blood to help heal faster, while UBM provides a structure for new tissue to grow. The study aims to see if these additions reduce pain, improve healing, and are cost-effective. PRP has been studied for its efficacy in treating anal fistulas, showing potential benefits in healing.
Who is the study for?
This trial is for English or Spanish speakers who can consent and have complex anal fistulas needing surgery. Surgeons must do at least 3 repairs a year. Patients should be willing to have temporary drainage before repair but can't join if they can't follow up for a year, have platelet disorders, very low platelet counts, take certain blood thinners, or their fistula is due to IBD, cancer, or radiation.
What is being tested?
The study tests if adding autologous PRP (from the patient's own blood) and/or porcine urinary bladder matrix improves healing after anal fistula surgery compared to usual care alone. It looks at recurrence rates, quality of life post-surgery, pain levels, fecal continence and cost-effectiveness.
What are the potential side effects?
Potential side effects may include discomfort from PRP injections and risks associated with surgical procedures such as infection or issues with wound healing. The specific side effects of the urinary bladder matrix are not detailed but could involve similar surgical risks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Health-related quality of life (HRQoL) as assessed by the EQ-5D-5L questionnaire
Number of participants with fistula recurrence
Secondary study objectives
Change in fecal continence as assessed by the Cleveland Clinic Fecal Incontinence (CCFI) scoring tool
Number of participants who have post operative pain as assessed by the visual analog scale (VAS)
The relative cost utility of the different treatment strategies as assessed by a questionnaire
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Surgery plus platelet-rich plasma (PRP)Experimental Treatment2 Interventions
Group II: Surgery plus matrixExperimental Treatment2 Interventions
Group III: Surgery plus PRP plus matrix materialExperimental Treatment3 Interventions
Group IV: SurgeryPlacebo Group1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Matrix
2015
N/A
~10
Surgery
2000
Completed Phase 3
~2490
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for anal fistulas, such as Autologous Platelet-Rich Plasma (PRP) and Micronized Acellular Porcine Urinary Bladder Matrix (UBM), work by promoting tissue healing and providing a scaffold for tissue regeneration. PRP delivers growth factors and cytokines that accelerate the body's natural healing processes and reduce inflammation.
UBM supports the growth of new, healthy tissue to replace damaged areas. These mechanisms are essential for anal fistula patients as they enhance healing, reduce recurrence rates, and improve overall quality of life.
Meta-analysis of platelet-rich plasma therapy for anal fistula.Fistula tract curettage and the use of biological dermal plugs improve high transsphincteric fistula healing in an animal model.
Meta-analysis of platelet-rich plasma therapy for anal fistula.Fistula tract curettage and the use of biological dermal plugs improve high transsphincteric fistula healing in an animal model.
Find a Location
Who is running the clinical trial?
CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCESUNKNOWN
The University of Texas Health Science Center, HoustonLead Sponsor
936 Previous Clinical Trials
335,681 Total Patients Enrolled
Jeffrey L Van Eps, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having surgery for a complex anal fistula.I am willing to have a temporary anal seton drainage before repair.I can speak English or Spanish and can give informed consent.I have a disorder that affects my platelets.I perform at least 3 repair procedures a year.I cannot stop taking my blood thinner for more than 5 days before surgery.I have a fistula due to IBD, cancer, or radiation in the pelvic area.I am having surgery for a complex anal fistula.
Research Study Groups:
This trial has the following groups:- Group 1: Surgery plus PRP plus matrix material
- Group 2: Surgery plus matrix
- Group 3: Surgery
- Group 4: Surgery plus platelet-rich plasma (PRP)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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