Skip to main content
OpenTrials
Completed

NCT Number: NCT07294612

Use of Platelet-Rich Fibrin in Bladder Exstrophy Repair

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bladder Exstrophy-Epispadias Complex Bladder Exstrophy Bladder Exstrophy and Epispadias Complex Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Abnormalities Urogenital Diseases Urologic Diseases

Age range

6 month–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Zafar

Tashkent, 100020, Uzbekistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard Surgical Closure

Procedure

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

Primary outcomes

  1. Incidence of Penopubic Fistula

    Time frame: from 3 month to 6 month

    Occurrence of clinically confirmed penopubic fistula following primary bladder exstrophy repair in the PRF and non-PRF groups.

Secondary outcomes

  1. Incidence of Wound Dehiscence

    Time frame: Within 6 months after surgery

    Occurrence of postoperative wound dehiscence after primary bladder exstrophy repair in the PRF and non-PRF groups.

Sponsors and collaborators

Lead sponsor

National Children's Medical Center, Uzbekistan

Other

Registry information

Official study title

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

Acronym: PRF-BEEC

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.