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

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

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.

Study Overview

• Status: Completed
• Conditions: Bladder Exstrophy-Epispadias Complex
• Intervention / Treatment: Biological: Autologous Platelet-Rich Fibrin; Procedure: Standard Surgical Closure

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uzbekistan
  • Tashkent
    • Tashkent, Tashkent, Uzbekistan, 100020
      • Zafar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRF Group; Participants undergo primary bladder exstrophy repair with intraoperative application of autologous platelet-rich fibrin over the bladder neck before pubic symphysis closure.	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.
Active Comparator: Non-PRF Group; Participants undergo standard primary bladder exstrophy repair without the use of platelet-rich fibrin.	Procedure: Standard Surgical Closure; Standard primary bladder exstrophy repair closure performed without the use of platelet-rich fibrin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Penopubic Fistula	Occurrence of clinically confirmed penopubic fistula following primary bladder exstrophy repair in the PRF and non-PRF groups.	from 3 month to 6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Wound Dehiscence	Occurrence of postoperative wound dehiscence after primary bladder exstrophy repair in the PRF and non-PRF groups.	Within 6 months after surgery

Collaborators and Investigators

• Sponsor: National Children's Medical Center, Uzbekistan

Publications and helpful links

General Publications

• Dohan Ehrenfest DM, Rasmusson L, Albrektsson T. Classification of platelet concentrates: from pure platelet-rich plasma (P-PRP) to leucocyte- and platelet-rich fibrin (L-PRF). Trends Biotechnol. 2009 Mar;27(3):158-67. doi: 10.1016/j.tibtech.2008.11.009. Epub 2009 Jan 31.
• Kajbafzadeh AM, Abolghasemi H, Eshghi P, Alizadeh F, Elmi A, Shafaattalab S, Dianat S, Amirizadeh N, Mohseni MJ. Single-donor fibrin sealant for repair of urethrocutaneous fistulae following multiple hypospadias and epispadias repairs. J Pediatr Urol. 2011 Aug;7(4):422-7. doi: 10.1016/j.jpurol.2010.06.004. Epub 2010 Jul 15.
• Guinot A, Arnaud A, Azzis O, Habonimana E, Jasienski S, Fremond B. Preliminary experience with the use of an autologous platelet-rich fibrin membrane for urethroplasty coverage in distal hypospadias surgery. J Pediatr Urol. 2014 Apr;10(2):300-5. doi: 10.1016/j.jpurol.2013.09.026. Epub 2013 Nov 13.
• Soyer T, Cakmak M, Aslan MK, Senyucel MF, Kisa U. Use of autologous platelet rich fibrin in urethracutaneous fistula repair: preliminary report. Int Wound J. 2013 Jun;10(3):345-7. doi: 10.1111/j.1742-481X.2012.00983.x. Epub 2012 May 9.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): January 10, 2025
• Study Completion (Actual): March 15, 2025

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Estimated): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Wound Healing; Pediatric Urology; Platelet-Rich Fibrin; Bladder Exstrophy; Penopubic Fistula
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Congenital Abnormalities; Urinary Bladder Diseases; Urogenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bladder Exstrophy; Bladder Exstrophy and Epispadias Complex
• Other Study ID Numbers: №:052022/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No