NCT07294612

Use of Platelet-Rich Fibrin in Bladder Exstrophy Repair

Use of Platelet-Rich Fibrin in Bladder Exstrophy Repair: A Prospective Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National Children's Medical Center, Uzbekistan · Academic / Other
• Sex: Male
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-center, prospective, randomized controlled clinical trial conducted in the Pediatric Urology Department of the National Children's Medical Center between 2022 and 2025. The study enrolled 20 male patients with primary bladder exstrophy-epispadias complex undergoing initial surgical repair. Patients with cloacal variants and complicated cases were excluded. Participants were randomly allocated using a computer-generated random number sequence into two groups: the PRF group (n = 12), in which autologous platelet-rich fibrin was applied during bladder neck repair, and the non-PRF control group (n = 8), in which standard wound closure was performed without PRF. In the PRF group, 5-10 mL of venous blood was collected intraoperatively and centrifuged to prepare a PRF membrane, which was applied over the bladder neck before pubic symphysis closure. Both groups underwent standardized surgical repair techniques, including complete primary repair or modified staged repair as indicated. The primary outcome was the incidence of penopubic fistula formation. Secondary outcomes included wound dehiscence, hospital stay, and postoperative complications. Patients were followed postoperatively according to the institutional protocol. This study was approved by the Institutional Review Board of the National Children's Medical Center (Approval No.: 052022/14), and informed consent was obtained from the parents or legal guardians of all participants.

Conditions

• Bladder Exstrophy-Epispadias Complex

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Platelet-Rich Fibrin	Autologous platelet-rich fibrin prepared intraoperatively from 5-10 mL of the patient's venous blood using centrifugation at (3000 rpm for 10 min) to produce a PRF and applied over the bladder neck before pubic symphysis closure during primary bladder exstrophy repair.
PROCEDURE	Standard Surgical Closure	Standard primary bladder exstrophy repair closure performed without the use of platelet-rich fibrin.

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-01-10
• Completion: 2025-03-15
• First posted: 2025-12-19
• Last updated: 2025-12-29

Locations

1 site across 1 country: Uzbekistan