Long-term effectiveness of bioactive matrix with platelet concentrate in complex anal fistulae

Overview

This study evaluates the long-term healing rates and safety of regenerative fistula treatment (RFT) using the Obsidian RFT® bioactive matrix combined with autologous platelet concentrate in patients with complex anal fistulae (CAF). The treatment demonstrated promising clinical healing with minimal complications and preserved continence over a follow-up period of at least 6 months.

Background

Complex anal fistulae (CAF) present significant surgical challenges due to high recurrence rates and risk of continence disturbances. Traditional surgical options such as fistulotomy and advancement flaps have variable success and potential complications. Minimally invasive techniques and biocompatible materials like the Obsidian RFT® matrix, which promotes tissue regeneration through autologous platelets and growth factors, offer new therapeutic avenues. However, long-term outcome data for these novel treatments remain limited.

Data Highlights

The study included patients with CAF treated with RFT between February 2021 and June 2024, with a minimum follow-up of 6 months. Outcomes assessed were clinical healing defined by absence of discharge, adverse events, need for additional surgery, and continence status. The procedure involved seton placement, fistula tract debridement, internal orifice closure, and application of the bioactive matrix. Healing rates, recurrence, and continence disturbances were monitored.

Key Findings

• RFT with Obsidian RFT® matrix achieved significant long-term clinical healing in patients with complex anal fistulae.
• The procedure was well tolerated with a low incidence of adverse events and complications.
• Continence was preserved or not worsened in the majority of patients post-treatment.
• RFT is compatible with various fistula anatomies including extrasphincteric, intersphincteric, transsphincteric, and suprasphincteric types.
• The treatment respects anal canal anatomy and physiology, contributing to its safety profile.
• Long-term follow-up demonstrated sustained fistula closure and low recurrence rates.

Clinical Implications

RFT using the Obsidian RFT® bioactive matrix combined with autologous platelet concentrate represents a promising minimally invasive option for managing complex anal fistulae, balancing effective healing with sphincter preservation. Clinicians should consider this approach especially in patients at high risk for continence disturbances or recurrence after conventional surgery. Careful patient selection and control of underlying inflammatory bowel disease are essential for optimal outcomes.

Conclusion

The use of a bioactive autologous matrix with platelet concentrate in RFT offers an effective and safe long-term treatment for complex anal fistulae, with favorable healing rates and minimal impact on continence. Further studies with larger cohorts are warranted to confirm these findings.

References

1. Vall d’Hebron University Hospital Study 2021-2024 -- Long-term effectiveness of a bioactive matrix combined with autologous platelet concentrate in managing complex anal fistulae