Bladder Exstrophy-Epispadias ComplexPRF-BEECNCT07294612
Use of Platelet-Rich Fibrin in Bladder Exstrophy Repair
A study testing Autologous Platelet-Rich Fibrin and Standard Surgical Closure in people with Bladder Exstrophy-Epispadias Complex, run by National Children's Medical Center, Uzbekistan at 1 site in Uzbekistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 18 years, men only
- Conditions the study is for
- Bladder Exstrophy-Epispadias Complex
- What is being tested?
- Autologous Platelet-Rich Fibrin and Standard Surgical Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUzbekistan
- Study dates
- 1 Jan 2022to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bladder Exstrophy-Epispadias Complex
- Being tested
- Autologous Platelet-Rich Fibrin, Standard Surgical Closure
- Keywords
- Platelet-Rich Fibrin, Bladder Exstrophy, Penopubic Fistula, Pediatric Urology, Randomized Controlled Trial, Wound Healing
- Medical subject headings
- Bladder Exstrophy and Epispadias Complex, Bladder Exstrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet-Rich FibrinBiological
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 ClosureProcedure or surgery
Standard primary bladder exstrophy repair closure performed without the use of platelet-rich fibrin.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Autologous Platelet-Rich Fibrin |
| Non-PRF Group | Active comparator | Participants undergo standard primary bladder exstrophy repair without the use of platelet-rich fibrin. Receives: Procedure: Standard Surgical Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Penopubic Fistula
Occurrence of clinically confirmed penopubic fistula following primary bladder exstrophy repair in the PRF and non-PRF groups.
Measured: from 3 month to 6 month
Secondary outcomes (1)
Incidence of Wound Dehiscence
Occurrence of postoperative wound dehiscence after primary bladder exstrophy repair in the PRF and non-PRF groups.
Measured: Within 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start1 Jan 2022
- Primary completion10 Jan 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bladder Exstrophy-Epispadias ComplexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Children's Medical Center, Uzbekistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zafar Abdullaev, National Children's Medical Center, Uzbekistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294612
- Sponsor's protocol ID
- №:052022/14
- Acronym
- PRF-BEEC
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19187989Kajbafzadeh 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.
PubMed 20634140Guinot 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.
PubMed 24325905Soyer 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.
PubMed 22568526
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Platelet-Rich Fibrin in Bladder Exstrophy Repair: A Prospective Study
- ClinicalTrials.gov ID
- NCT07294612
- Acronym / sponsor ID
- PRF-BEEC / №:052022/14
- Conditions
- Bladder Exstrophy-Epispadias Complex
- Keywords
- Platelet-Rich Fibrin, Bladder Exstrophy, Penopubic Fistula, Pediatric Urology, Randomized Controlled Trial, Wound Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Children's Medical Center, UzbekistanUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| PRF Group | Experimental | Biological: Autologous Platelet-Rich FibrinParticipants undergo primary bladder exstrophy repair with intraoperative application of autologous platelet-rich fibrin over the bladder neck before pubic symphysis closure. |
| Non-PRF Group | Active comparator | Procedure: Standard Surgical ClosureParticipants undergo standard primary bladder exstrophy repair without the use of platelet-rich fibrin. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Platelet-Rich FibrinAutologous 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. | Biological | PRF Group |
| Standard Surgical ClosureStandard primary bladder exstrophy repair closure performed without the use of platelet-rich fibrin. | Procedure or surgery | Non-PRF Group |
Primary outcome
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.
1 secondary outcome
Incidence of Wound Dehiscence
Time frame: Within 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Background: PubMed 19187989Dohan 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.
- Results publication: PubMed 20634140Kajbafzadeh 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.
- Results publication: PubMed 24325905Guinot 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.
- Results publication: PubMed 22568526Soyer 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Platelet-Rich Fibrin and Standard Surgical Closure in people with Bladder Exstrophy-Epispadias Complex, run by National Children's Medical Center, Uzbekistan at 1 site in Uzbekistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Penopubic Fistula (time frame: from 3 month to 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07294612, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.