Clinical Trial

Use of Platelet-Rich Fibrin in Bladder Exstrophy Repair

Study acronym: PRF-BEEC
Completed
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-08.
Trial Details
NCT Number NCT07294612
Lead Sponsor National Children's Medical Center, Uzbekistan
Conditions Bladder Exstrophy-Epispadias Complex
Enrollment 20 participants
Start Date 2022-01-01
Primary Completion 2025-01-10 (estimated)
Study Completion 2025-03-15 (estimated)
Updated on ClinicalTrials.gov 2025-12-29