Biologic Augmented Repair for Anal Fistulas

(BIO RAMP Trial)

Overseen By Angielyn Rivera

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Anti-platelet agents

Disqualifiers: IBD, Malignancy, Radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to enhance the surgical repair of complex anal fistulas. Researchers compare standard surgery with surgeries enhanced by either a special matrix material (Micronized Acellular Porcine Urinary Bladder Matrix), platelet-rich plasma (PRP), or both. The aim is to determine if these additions can reduce the recurrence of the fistula, lessen post-surgery pain, and improve quality of life. Individuals with a complex anal fistula undergoing specific surgical procedures may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative surgical advancements and potentially improve personal outcomes.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both autologous PRP (platelet-rich plasma) and the micronized acellular porcine urinary bladder matrix (UBM) are generally safe for treating anal fistulas.

For the matrix, studies have reported no negative side effects, making it a promising and safe option for repairing anal fistulas. Derived from pig bladder tissue, this matrix aids in rebuilding tissue, supporting healing and wound repair.

Regarding PRP, made from a patient's own blood, studies have shown it is safe, especially when combined with other treatments. PRP has demonstrated safety in similar conditions, such as perianal Crohn's disease, where it showed good healing rates and no major safety concerns.

In summary, previous studies have shown both treatments to be well-tolerated and safe, with no significant safety issues reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatment for anal fistulas, which typically involves surgical methods like the ligation of intersphincteric tract (LIFT) or advancement flap technique, the investigational treatments in this trial introduce biologic elements to enhance healing. Researchers are excited about using matrix material and platelet-rich plasma (PRP) because these biologics have the potential to promote tissue regeneration and faster healing. Matrix material acts as a scaffold to support new tissue growth, while PRP is rich in growth factors that can accelerate the body’s natural repair processes. Adding these elements to traditional surgery could improve outcomes by reducing healing time and recurrence rates.

What evidence suggests that this trial's treatments could be effective for anal fistulas?

This trial will evaluate different treatment approaches for anal fistulas. One arm will involve surgery plus a special material from pig bladder, known as the matrix. Research has shown this to be very effective, with one study reporting an 89.3% success rate. Another arm will involve surgery plus platelet-rich plasma (PRP), which has also proven effective, achieving a success rate of 83.12% when combined with other treatments. Additionally, there is an arm combining surgery with both PRP and matrix material. These treatments are promising, especially when used together, and they offer a safe and effective way to manage anal fistulas. Findings suggest that using these biological materials can help reduce the chance of fistulas recurring and improve quality of life. ^{1 2 3 6 7}

Who Is on the Research Team?

Jeffrey L Van Eps, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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 perform at least 3 repair procedures a year.

Exclusion Criteria

Thrombocytopenia < 150 plt/microliter

Unable to reliably complete follow up for 12 months postoperatively

I have a disorder that affects my platelets.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Matrix
• Platelet-rich plasma (PRP)

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05805449?recrs=ab

BIOlogic Augmented Repair of Complex Anal Fistula Using ... The purpose of this study is to compare the clinical effectiveness of augmenting surgical repair of complex anal fistula using autologous PRP and/or ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41041688/

A Pilot Study of Porcine Acellular Bladder Matrix Filling in ... Results: The overall success rate was 89.3%, with an efficacy rate of 90.6% for all treated fistulas. Of the three patients who experienced ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12257961/

Outcomes of Complex Wound Reconstruction in High-Risk ... This retrospective case series examines the outcomes of urinary bladder matrix for the treatment of complex wounds in 21 patients deemed high- ...

4. researchgate.net researchgate.net/publication/396166890_A_Pilot_Study_of_Porcine_Acellular_Bladder_Matrix_Filling_in_the_Treatment_of_Anal_Fistulas_A_Single-Center_Cohort_Study

A Pilot Study of Porcine Acellular Bladder Matrix Filling in ... Results The overall success rate was 89.3%, with an efficacy rate of 90.6% for all treated fistulas. Of the three patients who experienced ...

5. smartpatients.com smartpatients.com/trials/NCT05805449

BIOlogic Augmented Repair of Complex Anal Fistula Using ... The purpose of this study is to compare the clinical effectiveness of augmenting surgical repair of complex anal fistula using autologous PRP and/or ...

6. products.integralife.com products.integralife.com/file/products/appealing_a_claim_determination_packet_micromatrix_4_25.pdf

Medicare Appeal Packet for MicroMatrix® UBM (Urinary ... MicroMatrix™ is composed of a porcine-derived extracellular matrix known as urinary bladder matrix. The device is supplied in a particle form in units up to ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05805449/biologic-augmented-repair-of-complex-anal-fistula-using-acellular-matrix-and-or-autologous-platelet-rich-plasma

BIOlogic Augmented Repair of Complex Anal Fistula Using ... The purpose of this study is to compare the clinical effectiveness of augmenting surgical repair of complex anal fistula using autologous ...