Use of Platelet-Rich Fibrin in Bladder Exstrophy Repair

NCT07294612 | Completed DMC

• 1 other identifier: №:052022/14
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Exstrophy-Epispadias Complex

Keywords

Platelet-Rich Fibrin; Bladder Exstrophy; Penopubic Fistula; Pediatric Urology; Randomized Controlled Trial; Wound Healing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of Wound Dehiscence

  Within 6 months after surgery

Study Arms (2)

PRF Group

EXPERIMENTAL

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

Non-PRF Group

ACTIVE COMPARATOR

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

Procedure: Standard Surgical Closure

Interventions

Autologous Platelet-Rich Fibrin BIOLOGICAL

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.

PRF Group

Standard Surgical Closure PROCEDURE

Standard primary bladder exstrophy repair closure performed without the use of platelet-rich fibrin.

Non-PRF Group

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Children's Medical Center, Uzbekistan: lead

Study Sites (1)

Zafar

Tashkent, Tashkent, 100020, Uzbekistan

Location

Related Publications (4)

• 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.

  PMID: 19187989 BACKGROUND

• 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.

  PMID: 20634140 RESULT

• 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.

  PMID: 24325905 RESULT

• 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.

  PMID: 22568526 RESULT

MeSH Terms

Conditions

Bladder Exstrophy and Epispadias Complex; Bladder Exstrophy

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pediatric urology department

Model Details: This is a parallel-group randomized controlled trial in which participants were assigned in a 1:1 ratio to either receive autologous platelet-rich fibrin during bladder exstrophy repair or undergo standard surgical closure without PRF. Outcomes were compared between the two independent groups

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: January 1, 2022
• Primary Completion: January 10, 2025
• Study Completion: March 15, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1)