Biologic Augmented Repair for Anal Fistulas

(BIO RAMP Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jeffrey L Van Eps, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Anti-platelet agents

Disqualifiers: IBD, Malignancy, Radiation, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires participants to stop taking anti-platelet medications more than 5 days before surgery.

What data supports the effectiveness of this treatment for anal fistulas?

Research shows that platelet-rich plasma (PRP) can help in treating anal fistulas, especially those that are difficult to heal with surgery, by promoting tissue repair and healing.

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Is biologic augmented repair for anal fistulas safe for humans?

Platelet-rich plasma (PRP), a component of biologic augmented repair, has been used in various medical treatments and is generally considered safe. Studies have shown it can improve tissue repair and has been used in conditions like urinary tract infections and bladder issues without significant safety concerns.

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How does the biologic augmented repair for anal fistulas differ from other treatments?

This treatment uses platelet-rich plasma (PRP), which is a component of blood that contains growth factors to help heal tissues, making it unique compared to traditional surgical methods. PRP is injected into the area around the fistula to promote healing and is considered minimally invasive, offering an alternative for patients who have not responded to surgery.

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Eligibility Criteria

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.

Inclusion 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.

Exclusion Criteria

Thrombocytopenia < 150 plt/microliter

Unable to reliably complete follow up for 12 months postoperatively

I have a disorder that affects my platelets.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical repair of complex anal fistula with or without biologic augmentation using PRP and/or UBM

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for early postoperative pain and fecal continence

2 weeks

1 visit (in-person), 1 visit (virtual)

Follow-up

Participants are monitored for fistula recurrence, HRQoL, and fecal continence

12 months

Multiple visits (in-person and virtual) at 1 week, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months post-surgery

Participant Groups

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.

Group I: Surgery plus platelet-rich plasma (PRP) Experimental Treatment 2 Interventions

Group II: Surgery plus matrix Experimental Treatment 2 Interventions

Group III: Surgery plus PRP plus matrix material Experimental Treatment 3 Interventions

Group IV: Surgery Placebo Group 1 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The University of Texas Health Science Center at Houston Houston, TX

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston Lead Sponsor

CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCES Collaborator

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Platelet-Rich Plasma Injections as Prophylaxis for Recurrent Urinary Tract Infection in Women. [2023] To investigate the therapeutic efficacy of intravesical platelet-rich plasma (PRP) injections as prophylaxis for adult women with recurrent urinary tract infection (rUTI).

2. Brazil pubmed.ncbi.nlm.nih.gov

Histological response to platelet-rich plasma added to polypropylene mesh implemented in rabbits. [2019] The platelet-rich plasma (PRP) is part of a set of biotechnologies, providing some growth factors that promote repair of different tissues. The polypropylene meshes (PPM) are applied in the correction of abdominal defects, pelvic floor and urinary incontinence, however, they induce many significant complications, as a result of an inappropriate inflammatory response.

3. Iran pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich-plasma injection and platelet-rich fibrin glue interposition for treatment of anal fistula resistant to surgery. [2023] The current study purposed to evaluate the autologous platelet-rich plasma (PRP), and platelet-rich fibrin glue (PRFG) effect on the treatment of complex, and recalcitrant anal fistula (AF) which was not cured by several surgeries.

4. England pubmed.ncbi.nlm.nih.gov

Meta-analysis of platelet-rich plasma therapy for anal fistula. [2022] To systematically evaluate the efficacy of platelet-rich plasma (PRP) in treating anal fistula.

5. Australia pubmed.ncbi.nlm.nih.gov

Urothelial health after platelet-rich plasma injection in intractable recurrent urinary tract infection: Improved cell proliferation, cytoskeleton, and barrier function protein expression. [2022] This clinical study used autologous intravesical platelet-rich plasma (PRP) injections to treat patients with recurrent urinary tract infection (rUTI). Changes in urothelial proliferation, cytoskeleton, and barrier function protein expression after treatment were investigated.

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety and feasibility of platelet rich fibrin matrix injections for treatment of common urologic conditions. [2022] Autologous platelet rich plasma (PRP) is used increasingly in a variety of settings. PRP injections have been used for decades to improve angiogenesis and wound healing. They have also been offered commercially in urology with little to no data on safety or efficacy. PRP could theoretically improve multiple urologic conditions, such as erectile dysfunction (ED), Peyronie's disease (PD), and stress urinary incontinence (SUI). A concern with PRP, however, is early washout, a situation potentially avoided by conversion to platelet rich fibrin matrix (PRFM). Before clinical trials can be performed, safety analysis is desirable. We reviewed an initial series of patients receiving PRFM for urologic pathology to assess safety and feasibility.

7. Switzerland pubmed.ncbi.nlm.nih.gov

Changes in the Ultrastructure of the Bladder Urothelium in Patients with Interstitial Cystitis after Intravesical Injections of Platelet-Rich Plasma. [2022] Urothelial dysfunction is considered a key pathological mechanism of interstitial cystitis/bladder pain syndrome (IC/BPS). Intravesical platelet-rich plasma (PRP) injections might be effective for treating IC/BPS. This prospective study investigated the changes in electron microscopic findings among IC/BPS patients after intravesical PRP injections. Twenty-six patients with refractory non-ulcer IC/BPS underwent monthly intravesical PRP injections for 4 months. Changes in clinical symptom scores and video urodynamic study parameters were assessed from baseline to after the PRP injections. A post-treatment Global Response Assessment (GRA) score ≥ 2 was considered a successful outcome. The mean GRA score was significantly higher after 4 PRP injections than at baseline. Approximately 42% of patients experienced successful outcomes after PRP treatment. Urothelial ultrastructural defects showed no significant differences between baseline and after the PRP injections. However, patients showed variable improvements in different urothelial defects (grade improvements: urothelium cell layers, 31%; umbrella cell integrity, 42%; umbrella cell surface uroplakin plaque, 54%; tight junctions between adjacent umbrella cells, 46%; lysed organelles, 58%; inflammatory cell infiltration, 31%). Patients with successful treatment outcomes showed significant improvements in urothelial tight junction defects. Repeated intravesical PRP injections are effective for improving IC/BPS symptoms as they promote urothelial ultrastructural defect recovery.

8. Germany pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma in the treatment of anal fistula: a systematic review and meta-analysis. [2023] To analyse the safety and effectiveness of platelet-rich plasma (PRP) in anal fistula patients.

9. United States pubmed.ncbi.nlm.nih.gov

Minimally Invasive Treatment of Recurrent Anal Fistulas with Autologous Platelet-Rich Plasma Combined With Internal Orifice Closure. [2023] Minimally invasive procedures for the treatment of anal fistulas are gaining more and more popularity. For this purpose, Platelet-Rich Plasma (PRP) are administered to accelerate the healing process of various difficult wounds or lesions. The aim of this study was to evaluate preliminary results of PRP injection into the tissues adjacent to anal fistulas.