Biologic Augmented Repair for Anal Fistulas

(BIO RAMP Trial)

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. ^{1 2 3 4 5}

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. ^{1 2 5 6 7}

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. ^{2 3 4 8 9}

Research Team

Jeffrey L Van Eps, MD

Principal Investigator

The University of Texas Health Science Center, Houston

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

Treatment Details

Interventions

• Matrix (Biological Implant)
• Platelet-rich plasma (PRP) (Biological)

Trial Overview 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.

Participant Groups

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.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCES

Collaborator

Trials

1

Recruited

250+

Findings from Research

Intravesical platelet-rich plasma (PRP) injections significantly reduced the frequency of recurrent urinary tract infections (rUTIs) in women, with a decrease from 0.46 episodes per month at baseline to 0.28 after treatment, indicating potential efficacy as a prophylactic option.

The treatment success rate for PRP was 51.5%, comparable to 48% for continuous antibiotic treatment, suggesting that PRP could be a viable alternative for managing rUTIs, especially for patients with higher baseline voiding efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Platelet-Rich Plasma Injections as Prophylaxis for Recurrent Urinary Tract Infection in Women. Lee, YK., Kuo, HC.[2023]

In a study involving 30 female rabbits, the use of platelet-rich plasma (PRP) with polypropylene meshes (PPM) significantly reduced inflammatory cell presence at 90 days post-implantation, indicating a potential for improved healing.

PRP application led to increased production of collagen types I and III within seven days of implantation, suggesting that PRP enhances tissue repair processes associated with PPM use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histological response to platelet-rich plasma added to polypropylene mesh implemented in rabbits. Ávila, OR., Parizzi, NG., Souza, AP., et al.[2019]

The study evaluated the use of autologous platelet-rich plasma (PRP) and platelet-rich fibrin glue (PRFG) in treating complex anal fistulas that had not healed after multiple surgeries, involving 10 patients over a follow-up period of 10 to 84 months.

The treatment was found to be safe, with no complications reported, and resulted in the cessation of anal fistula leakage in 6 out of 10 patients, suggesting that PRP and PRFG can enhance healing rates when used alongside traditional surgical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich-plasma injection and platelet-rich fibrin glue interposition for treatment of anal fistula resistant to surgery. Abdollahi, A., Emadi, E., Hamidi Alamdari, D.[2023]

Platelet-rich plasma (PRP) treatment for anal fistula showed a pooled cure rate of 65% based on a meta-analysis of 9 studies involving 289 patients, indicating its efficacy.

The recurrence rate of anal fistula after PRP treatment was found to be low at 12%, suggesting that PRP is a safe option for patients and warrants further clinical investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of platelet-rich plasma therapy for anal fistula. Luo, Q., Zhou, P., Chang, S.[2022]

In a study of 22 patients with recurrent urinary tract infections (rUTI), autologous intravesical platelet-rich plasma (PRP) injections led to a successful treatment outcome in 63.6% of patients, significantly improving urothelial cell proliferation and protein expression related to bladder health.

The treatment resulted in increased expression of key proteins like CD34 and CK20, which are important for bladder function, suggesting that PRP injections can help restore urothelial health and potentially prevent future UTIs.

NCBI (Pubmed)

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. Jiang, YH., Jhang, JF., Hsu, YH., et al.[2022]

In a study of 17 patients receiving platelet rich fibrin matrix (PRFM) injections for urologic conditions, only minor adverse events like mild pain and bruising were reported, indicating a good safety profile.

No decline in erectile function was observed in patients evaluated with the International Index of Erectile Function (IIEF-5) scores, suggesting that PRFM may be a feasible treatment option for erectile dysfunction and other urologic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of platelet rich fibrin matrix injections for treatment of common urologic conditions. Matz, EL., Pearlman, AM., Terlecki, RP.[2022]

In a study of 26 patients with refractory non-ulcer interstitial cystitis/bladder pain syndrome (IC/BPS), monthly intravesical platelet-rich plasma (PRP) injections for 4 months led to a significant improvement in clinical symptoms, with 42% of patients reporting successful outcomes.

While overall urothelial ultrastructural defects did not show significant changes, specific improvements were noted in areas such as umbrella cell integrity and tight junctions, particularly in patients who responded well to the treatment, indicating that PRP may help restore urothelial function.

NCBI (Pubmed)

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. Lee, YK., Jiang, YH., Jhang, JF., et al.[2022]

Platelet-rich plasma (PRP) treatment for anal fistula demonstrated a high overall cure rate of 72.11% across 14 studies involving 514 patients, with even better results (83.12% cure rate) when combined with other treatments.

PRP treatment showed a low recurrence rate of 14.84% and a low adverse event rate of 6.31%, indicating it is a safe and effective option for patients with anal fistula.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma in the treatment of anal fistula: a systematic review and meta-analysis. Wang, Y., Rao, Q., Ma, Y., et al.[2023]

In a study of 42 patients with recurrent anal fistulas, those who received Platelet-Rich Plasma (PRP) injections alongside surgical closure had a higher complete closure rate (75%) compared to those who did not receive PRP (45.5%).

PRP treatment not only promotes healing but also allows for multiple applications if initial closure is incomplete, making it a valuable option for patients with challenging anal fistulas while preserving anal sphincter function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally Invasive Treatment of Recurrent Anal Fistulas with Autologous Platelet-Rich Plasma Combined With Internal Orifice Closure. Cwaliński, J., Hermann, J., Paszkowski, J., et al.[2023]

References

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

Effectiveness of Platelet-Rich Plasma Injections as Prophylaxis for Recurrent Urinary Tract Infection in Women. [2023]

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

Histological response to platelet-rich plasma added to polypropylene mesh implemented in rabbits. [2019]

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]

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

Meta-analysis of platelet-rich plasma therapy for anal fistula. [2022]

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]

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

Safety and feasibility of platelet rich fibrin matrix injections for treatment of common urologic conditions. [2022]

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]

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

Platelet-rich plasma in the treatment of anal fistula: a systematic review and meta-analysis. [2023]

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]