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Use of Platelet-Rich Fibrin in Bladder Exstrophy Repair

NCT ID: NCT07294612

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-03-15

Brief Summary

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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

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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

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Bladder Exstrophy-Epispadias Complex

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PRF Group

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

Group Type EXPERIMENTAL

Autologous Platelet-Rich Fibrin

Intervention Type 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.

Non-PRF Group

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

Group Type ACTIVE_COMPARATOR

Standard Surgical Closure

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type BIOLOGICAL

Standard Surgical Closure

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Children's Medical Center, Uzbekistan

OTHER

Sponsor Role lead

Responsible Party

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Zafar Abdullaev

Head of Pediatric urology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zafar

Tashkent, Tashkent, Uzbekistan

Site Status

Countries

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Uzbekistan

References

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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.

Reference Type BACKGROUND
PMID: 19187989 (View on PubMed)

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.

Reference Type RESULT
PMID: 20634140 (View on PubMed)

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.

Reference Type RESULT
PMID: 24325905 (View on PubMed)

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.

Reference Type RESULT
PMID: 22568526 (View on PubMed)

Other Identifiers

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№:052022/14

Identifier Type: -

Identifier Source: org_study_id