Clinical Research Directory
Browse clinical research sites, groups, and studies.
FiLaC and PRGF-Endoret for Multi-recurrent Cryptoglandular Perianal Fistula (PLASMA Pilot Study)
Sponsor: Complejo Hospitalario Universitario de Santiago
Summary
Multi-recurrent cryptoglandular perianal fistula represents a challenging clinical problem with no established surgical solution after repeated failures. This pilot study evaluates the combination of fistula-tract laser closure (FiLaC) with perilesional injection of autologous platelet-rich growth factor (PRGF-Endoret) in 25 patients with a long-standing seton and no active sepsis. The primary outcome is clinical cure at 12 months. This study will provide preliminary safety and efficacy data to inform the design of a future randomised trial
Official title: Fistula-Tract Laser Closure (FiLaC) Combined With Perilesional Autologous PRGF-Endoret Injection for Multi-Recurrent Cryptoglandular Perianal Fistula: A Prospective Single-Arm Pilot Study
Key Details
Gender
All
Age Range
Any - 18 Years
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2026-10-01
Completion Date
2029-03-30
Last Updated
2026-09-09
Healthy Volunteers
No
Conditions
Interventions
Laser ablation of fistula tract using 1000-µm radial fibre (Biolitec, 1470 nm, 12 W, continuous, 1 mm/s withdrawal). Internal opening closed with Vicryl 2/0 suture in all patients
Perilesional injection of 7 ml of autologous platelet-rich growth factor (PRGF-Endoret; BTI Biotechnology Institute, Vitoria, Spain), prepared from 36 ml of peripheral venous blood collected in four 9-ml sodium citrate tubes, centrifuged at 580 rpm for 8 minutes. The platelet-rich fraction, free of leucocytes and erythrocytes, is activated with autologous calcium chloride solution (0.05 ml of CaCl₂ 10% per ml of PRGF) immediately before injection and administered perilesionally around the fistula tract and internal opening closure site using a 23-gauge needle under direct vision.