Biologic Augmented Repair for Anal Fistulas

(BIO RAMP 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.

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

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.

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.

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.¹²³⁶⁷