Use of Platelet-Rich Fibrin in Bladder Exstrophy Repair (PRF-BEEC)

National Children's Medical Center, Uzbekistan

Status: Completed

Conditions: Bladder Exstrophy-Epispadias Complex

Treatments: Biological: Autologous Platelet-Rich Fibrin; Procedure: Standard Surgical Closure

Study type: Interventional

Funder types: Other

Identifiers

NCT07294612

№:052022/14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Male

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male patients diagnosed with primary bladder exstrophy-epispadias complex (BEEC)
• Age from birth up to 18 years
• Patients undergoing primary surgical repair of bladder exstrophy
• Written informed consent provided by parents or legal guardians

Exclusion criteria

• Patients with cloacal variants of bladder exstrophy
• Patients with complicated or recurrent bladder exstrophy
• Patients who previously underwent bladder exstrophy repair
• Patients with severe associated congenital anomalies that could affect wound healing
• Patients with coagulation abnormalities
• Patients with severe anemia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

PRF Group

Experimental group

Description:

Participants undergo primary bladder exstrophy repair with intraoperative application of autologous platelet-rich fibrin over the bladder neck before pubic symphysis closure.

Treatment:

Biological: Autologous Platelet-Rich Fibrin

Non-PRF Group

Active Comparator group

Description:

Participants undergo standard primary bladder exstrophy repair without the use of platelet-rich fibrin.

Treatment:

Procedure: Standard Surgical Closure