drugset / Trial / NCT07294612

Use of Platelet-Rich Fibrin in Bladder Exstrophy Repair

NCT07294612 ↗

RandomizedParallel-groupOpen-labelPrevention

Summary

Bladder exstrophy-epispadias complex (BEEC) is a rare condition in which the bladder and surrounding structures do not form normally. Surgery is required to close the bladder and restore normal anatomy, but complications such as penopubic fistula and wound breakdown are common after repair. Platelet-rich fibrin (PRF) is a material obtained from a patient's own blood that contains healing factors and may improve wound healing. This prospective randomized controlled study evaluates whether applying autologous PRF during primary bladder exstrophy repair can reduce postoperative complications compared with standard surgical closure alone. Twenty pediatric patients with primary BEEC undergoing surgical repair were randomly assigned to either a PRF group or a non-PRF (control) group. The main outcome measured was the occurrence of penopubic fistula after surgery, along with other postoperative complications. The results of this study aim to help determine whether PRF is a safe and effective adjunct in bladder exstrophy repair.

Timeline

Start
2022-01-01
Primary completion
2025-01-10
Completion
2025-03-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Autologous Platelet-Rich Fibrin Unknown — —