PRFPRFNCT07045545
A Multicenter Randomized Controlled Trial Comparing Platelet-Rich Fibrin and Ventral Dartos Flap as Intermediate Layers in Tabularized Incised Plate (TIP) Urethroplasty for Distal Hypospadias With Mild Penile Curvature
A study testing - Group A: Platelet-rich fibrin membrane prepared intraoperatively and applied over neourethra and Group B: Ventral dartos flap rotated over neourethra in people with PRF and Hypospadias, run by National Children's Medical Center, Uzbekistan at 1 site in Uzbekistan.
Trial summary
Distal hypospadias is the most common form of hypospadias. The Tubularized Incised Plate (TIP) repair is the standard surgical technique for this condition; however, complications such as fistula formation and meatal stenosis remain concerns. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- PRF, Hypospadias, Distal Hypospadias
- What is being tested?
- - Group A: Platelet-rich fibrin membrane prepared intraoperatively and applied over neourethra and Group B: Ventral dartos flap rotated over neourethra
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUzbekistan
- Study dates
- 5 Jun 2025to 5 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Primary and complex distal hypospadias (Grade 1, Abbas classification)
- Penile curvature <30° after degloving (Methodology of curvature measurement: Abbas T. O. (2022).
- Children aged 6 months to 5 years
Who cannot join
- Previous hypospadias surgery
- Proximal hypospadias
- Penile curvature ≥30°
- Syndromic anomalies or coagulopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Distal hypospadias is the most common form of hypospadias. The Tubularized Incised Plate (TIP) repair is the standard surgical technique for this condition; however, complications such as fistula formation and meatal stenosis remain concerns. These complications are often influenced by the choice of intermediate tissue layer used to reinforce the neourethra. The traditional ventral dartos flap is effective but can be technically challenging and may result in a bulky tissue layer.
Platelet-rich fibrin (PRF) is an autologous, growth factor-rich biological material that has shown promise in tissue regeneration and healing. It is easy to prepare intraoperatively and may serve as a biological reinforcement to reduce postoperative complications.
This study aims to provide high-quality evidence comparing the effectiveness of PRF versus the ventral dartos flap in patients with distal hypospadias, specifically those with Grade 1 urethral defects and minimal penile curvature, using a stratified study population to ensure balanced groups.
Read the detailed description
This randomized controlled trial aims to compare the incidence of urethrocutaneous fistula at a minimum of 6 months postoperatively between two intermediate layers used in hypospadias repair: platelet-rich fibrin (PRF) membrane and ventral dartos flap. The study will also evaluate secondary outcomes, including rates of meatal stenosis, urethral stricture, other postoperative complications, and cosmetic outcomes assessed by standardized photographs and blinded expert scoring.
Study Design and Setting:
This prospective, multicenter, single-blinded randomized controlled trial will be conducted at centers in Tashkent, Uzbekistan, and Jakarta, Indonesia. A total of 140 patients (70 per group) will be enrolled, with randomization stratified by urethral plate score and center to ensure balanced groups.
Participants:
Children aged 6 months to 5 years with primary distal hypospadias (Grade 1, Abbas classification) or redo distal hypospadias (Grade 1, Abbas classification), with penile curvature less than 30° after degloving (measured as per Abbas, 2022), will be included. Exclusion criteria include previous hypospadias surgery, proximal hypospadias, penile curvature ≥30°, or syndromic anomalies/coagulopathies.
Interventions:
Participants will undergo tubularized incised plate (TIP) or glanuloplasty TIP (GTIP) urethroplasty performed by experienced pediatric urologists using standardized techniques.
Group A: Application of autologous platelet-rich fibrin membrane over the neourethra. PRF will be prepared intraoperatively by drawing 10 mL of peripheral blood, centrifuging at 3000 rpm for 10 minutes, extracting the PRF clot, compressing it into a membrane, and securing it over the neourethra with absorbable sutures.
Group B: Rotation of a ventral dartos flap over the neourethra.
Intraoperative PRF Preparation:
Blood will be collected into sterile glass tubes without anticoagulants, centrifuged immediately, and the PRF membrane prepared as described. The membrane will be placed over the neourethra before glans closure, secured laterally, and the skin closure completed in standard fashion.
Stratification:
Participants will be stratified based on urethral plate characteristics using a validated scoring system before randomization to ensure anatomical balance.
Follow-Up:
Patients will be assessed at 1, 3, and 6 months postoperatively for complications (fistula, stenosis, etc.), neomeatus function, and cosmetic appearance. Digital photographs will be evaluated by two blinded pediatric urologists, and cosmetic outcomes will be scored using the HOSE system.
Data Management and Analysis:
All data will be anonymized and stored securely. Statistical analysis will be performed using SPSS v22, applying appropriate tests for categorical and continuous variables, with multivariate regression if necessary.
- Conditions
- PRF, Hypospadias, Distal Hypospadias, Hypospadias Repair, Fistula Stenosis, Cosmetic Outcomes
- Being tested
- - Group A: Platelet-rich fibrin membrane prepared intraoperatively and applied over neourethra, Group B: Ventral dartos flap rotated over neourethra
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
- Group A: Platelet-rich fibrin membrane prepared intraoperatively and applied over neourethraProcedure or surgery
In this arm, a platelet-rich fibrin membrane will be prepared intraoperatively from the patient's blood using centrifugation. The prepared PRF membrane will then be applied directly over the neourethra following urethroplasty to promote healing and tissue regeneration.
Group B: Ventral dartos flap rotated over neourethraProcedure or surgery
Participants in this arm will undergo hypospadias repair with the application of a ventral dartos fascia flap. The procedure involves elevating a vascularized flap of ventral dartos fascia from the penile shaft, rotating it over the neourethra to provide additional tissue coverage and promote healing. This flap helps in reducing the risk of fistula formation and enhances vascular support to the neourethra. The surgical steps include dissecting the dartos fascia carefully, rotating it over the neourethral reconstruction, and securing it in place, followed by standard postoperative care and follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Group A: PRF applied over neourethra; | Experimental | * In patients randomized to the PRF group (Group A), autologous platelet-rich fibrin will be prepared intraoperatively using the following standardized protocol:
* Approximately 10 minutes before completion of urethroplasty, a 5-10 mL peripheral blood sample to be drawn from the cephalic vein under sterile conditions. The blood to be immediately transferred into a plain sterile glass tube without anticoagulants or additives. Centrifugation to be performed at 3000 rpm (approximately 400×g) for 10 minutes using a bench-top centrifuge.
* Following centrifugation, three distinct layers were formed:
1. Acellular plasma (top)
2. Platelet-rich fibrin clot (middle)
3. Red blood cells (bottom)
* The PRF clot to be carefully extracted using sterile forceps , and residual red blood cells were gently separated to ensure a clean PRF membrane. The PRF clot will then gently compressed between saline-soaked sterile gauze to form a pliable membrane suitable for surgical application. Receives: Procedure: - Group A: Platelet-rich fibrin membrane prepared intraoperatively and applied over neourethra |
| Group B: Ventral dartos flap rotated over neourethra | Active comparator | Participants in this arm will undergo hypospadias repair with the application of a ventral dartos fascia flap. The procedure involves elevating a vascularized flap of ventral dartos fascia from the penile shaft, rotating it over the neourethra to provide additional tissue coverage and promote healing. This flap helps in reducing the risk of fistula formation and enhances vascular support to the neourethra. The surgical steps include dissecting the dartos fascia carefully, rotating it over the neourethral reconstruction, and securing it in place, followed by standard postoperative care and follow-up. Receives: Procedure: Group B: Ventral dartos flap rotated over neourethra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypospadias Cosmetic Score (HOSE)
Assessment Method: Standardized digital photographs taken at 6 months postoperatively.
Evaluators: Two independent pediatric urologists blinded to treatment allocation will evaluate the photographs.
Measurement Tool: Cosmetic outcome scored using the Hypospadias Objective Scoring Evaluation (HOSE) system or a similar validated scale.
Units: HOSE score (range 5-10).
Higher scores: Indicate better cosmetic outcomes.
Measured: Follow-up evaluations will occur at 1, 3, and 6 months postoperatively.
Secondary outcomes (1)
Clinical examination for postoperative complications (fistula, stenosis, )
Assessment Method: Physical examination conducted by a trained clinician during follow-up visits at 1, 3, and 6 months post-surgery.
Measurement Tools: Visual inspection and palpation for fistula or stenosis; documentation of findings in standardized case report forms.
Units/Scoring: Presence or absence of complications (binary: yes/no).
Interpretation: Higher occurrence indicates worse outcome.
Measured: during follow-up visits at 1, 3, and 6 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start5 Jun 2025
- Primary completion5 Jun 2026 (estimated)
- Study completion5 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PRFStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Children's Medical Center, Uzbekistan
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital
- Responsible party
- Principal investigator, Zafar Abdullaev, National Children's Medical Center, Uzbekistan
- Investigators
- Tariq Abbas, MD, PhD, Study chair, Sidra Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045545
- Sponsor's protocol ID
- 0620251
- Acronym
- PRF
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abbas TO. Evaluation of penile curvature in patients with hypospadias; gaps in the current practice and future perspectives. J Pediatr Urol. 2022 Apr;18(2):151-159. doi: 10.1016/j.jpurol.2021.12.015. Epub 2021 Dec 31.
PubMed 35031224Abbas TO. An objective hypospadias classification system. J Pediatr Urol. 2022 Aug;18(4):481.e1-481.e8. doi: 10.1016/j.jpurol.2022.05.001. Epub 2022 May 11.
PubMed 35644790Elnashar AM, Albishbishy M, Sheir H, Elayyouti M, Elsherbiny M, Elzohiri M, Ghazaly Waly ME, Elsaied A. Comparative Study Between Autologous Platelet-rich Fibrin Membrane and Local Flaps as Intervening Layer in Management of Distal Hypospadias. J Pediatr Surg. 2025 Jan;60(1):161994. doi: 10.1016/j.jpedsurg.2024.161994. Epub 2024 Oct 11.
PubMed 39461004Guinot 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 24325905Moraschini V, Miron RJ, Mourao CFAB, Louro RS, Sculean A, da Fonseca LAM, Calasans Maia MD, Shibli JA. Antimicrobial effect of platelet-rich fibrin: A systematic review of in vitro evidence-based studies. Periodontol 2000. 2024 Feb;94(1):131-142. doi: 10.1111/prd.12529. Epub 2023 Sep 22.
PubMed 37740425Kajbafzadeh 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 20634140Soyer 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 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial Comparing Platelet-Rich Fibrin and Ventral Dartos Flap as Intermediate Layers in Tabularized Incised Plate (TIP) Urethroplasty for Distal Hypospadias With Mild Penile Curvature
- ClinicalTrials.gov ID
- NCT07045545
- Acronym / sponsor ID
- PRF / 0620251
- Conditions
- PRF, Hypospadias, Distal Hypospadias, Hypospadias Repair, Fistula Stenosis, Cosmetic Outcomes
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- National Children's Medical Center, UzbekistanUniversity, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 5 Jun 2026 (estimated)
- Study completion
- 5 Jun 2026 (estimated)
- First posted
- 1 Jul 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.
Distal hypospadias is the most common form of hypospadias. The Tubularized Incised Plate (TIP) repair is the standard surgical technique for this condition; however, complications such as fistula formation and meatal stenosis remain concerns. These complications are often influenced by the choice of intermediate tissue layer used to reinforce the neourethra. The traditional ventral dartos flap is effective but can be technically challenging and may result in a bulky tissue layer.
Platelet-rich fibrin (PRF) is an autologous, growth factor-rich biological material that has shown promise in tissue regeneration and healing. It is easy to prepare intraoperatively and may serve as a biological reinforcement to reduce postoperative complications.
This study aims to provide high-quality evidence comparing the effectiveness of PRF versus the ventral dartos flap in patients with distal hypospadias, specifically those with Grade 1 urethral defects and minimal penile curvature, using a stratified study population to ensure balanced groups.
Detailed description
This randomized controlled trial aims to compare the incidence of urethrocutaneous fistula at a minimum of 6 months postoperatively between two intermediate layers used in hypospadias repair: platelet-rich fibrin (PRF) membrane and ventral dartos flap. The study will also evaluate secondary outcomes, including rates of meatal stenosis, urethral stricture, other postoperative complications, and cosmetic outcomes assessed by standardized photographs and blinded expert scoring.
Study Design and Setting:
This prospective, multicenter, single-blinded randomized controlled trial will be conducted at centers in Tashkent, Uzbekistan, and Jakarta, Indonesia. A total of 140 patients (70 per group) will be enrolled, with randomization stratified by urethral plate score and center to ensure balanced groups.
Participants:
Children aged 6 months to 5 years with primary distal hypospadias (Grade 1, Abbas classification) or redo distal hypospadias (Grade 1, Abbas classification), with penile curvature less than 30° after degloving (measured as per Abbas, 2022), will be included. Exclusion criteria include previous hypospadias surgery, proximal hypospadias, penile curvature ≥30°, or syndromic anomalies/coagulopathies.
Interventions:
Participants will undergo tubularized incised plate (TIP) or glanuloplasty TIP (GTIP) urethroplasty performed by experienced pediatric urologists using standardized techniques.
Group A: Application of autologous platelet-rich fibrin membrane over the neourethra. PRF will be prepared intraoperatively by drawing 10 mL of peripheral blood, centrifuging at 3000 rpm for 10 minutes, extracting the PRF clot, compressing it into a membrane, and securing it over the neourethra with absorbable sutures.
Group B: Rotation of a ventral dartos flap over the neourethra.
Intraoperative PRF Preparation:
Blood will be collected into sterile glass tubes without anticoagulants, centrifuged immediately, and the PRF membrane prepared as described. The membrane will be placed over the neourethra before glans closure, secured laterally, and the skin closure completed in standard fashion.
Stratification:
Participants will be stratified based on urethral plate characteristics using a validated scoring system before randomization to ensure anatomical balance.
Follow-Up:
Patients will be assessed at 1, 3, and 6 months postoperatively for complications (fistula, stenosis, etc.), neomeatus function, and cosmetic appearance. Digital photographs will be evaluated by two blinded pediatric urologists, and cosmetic outcomes will be scored using the HOSE system.
Data Management and Analysis:
All data will be anonymized and stored securely. Statistical analysis will be performed using SPSS v22, applying appropriate tests for categorical and continuous variables, with multivariate regression if necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: PRF applied over neourethra; | Experimental | Procedure: - Group A: Platelet-rich fibrin membrane prepared intraoperatively and applied over neourethra* In patients randomized to the PRF group (Group A), autologous platelet-rich fibrin will be prepared intraoperatively using the following standardized protocol: * Approximately 10 minutes before completion of urethroplasty, a 5-10 mL peripheral blood sample to be drawn from the cephalic vein under sterile conditions. The blood to be immediately transferred into a plain sterile glass tube without anticoagulants or additives. Centrifugation to be performed at 3000 rpm (approximately 400×g) for 10 minutes using a bench-top centrifuge. * Following centrifugation, three distinct layers were formed: 1. Acellular plasma (top) 2. Platelet-rich fibrin clot (middle) 3. Red blood cells (bottom) * The PRF clot to be carefully extracted using sterile forceps , and residual red blood cells were gently separated to ensure a clean PRF membrane. The PRF clot will then gently compressed between saline-soaked sterile gauze to form a pliable membrane suitable for surgical application. |
| Group B: Ventral dartos flap rotated over neourethra | Active comparator | Procedure: Group B: Ventral dartos flap rotated over neourethraParticipants in this arm will undergo hypospadias repair with the application of a ventral dartos fascia flap. The procedure involves elevating a vascularized flap of ventral dartos fascia from the penile shaft, rotating it over the neourethra to provide additional tissue coverage and promote healing. This flap helps in reducing the risk of fistula formation and enhances vascular support to the neourethra. The surgical steps include dissecting the dartos fascia carefully, rotating it over the neourethral reconstruction, and securing it in place, followed by standard postoperative care and follow-up. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Primary and complex distal hypospadias (Grade 1, Abbas classification)
- Penile curvature <30° after degloving (Methodology of curvature measurement: Abbas T. O. (2022).
- Children aged 6 months to 5 years
Key exclusion criteria (4 listed)
- Previous hypospadias surgery
- Proximal hypospadias
- Penile curvature ≥30°
- Syndromic anomalies or coagulopathy
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 |
|---|---|---|
| - Group A: Platelet-rich fibrin membrane prepared intraoperatively and applied over neourethraIn this arm, a platelet-rich fibrin membrane will be prepared intraoperatively from the patient's blood using centrifugation. The prepared PRF membrane will then be applied directly over the neourethra following urethroplasty to promote healing and tissue regeneration. | Procedure or surgery | Group A: PRF applied over neourethra; |
| Group B: Ventral dartos flap rotated over neourethraParticipants in this arm will undergo hypospadias repair with the application of a ventral dartos fascia flap. The procedure involves elevating a vascularized flap of ventral dartos fascia from the penile shaft, rotating it over the neourethra to provide additional tissue coverage and promote healing. This flap helps in reducing the risk of fistula formation and enhances vascular support to the neourethra. The surgical steps include dissecting the dartos fascia carefully, rotating it over the neourethral reconstruction, and securing it in place, followed by standard postoperative care and follow-up. | Procedure or surgery | Group B: Ventral dartos flap rotated over neourethra |
Primary outcome
Hypospadias Cosmetic Score (HOSE)
Time frame: Follow-up evaluations will occur at 1, 3, and 6 months postoperatively.
Assessment Method: Standardized digital photographs taken at 6 months postoperatively. Evaluators: Two independent pediatric urologists blinded to treatment allocation will evaluate the photographs. Measurement Tool: Cosmetic outcome scored using the Hypospadias Objective Scoring Evaluation (HOSE) system or a similar validated scale. Units: HOSE score (range 5-10). Higher scores: Indicate better cosmetic outcomes.
1 secondary outcome
Clinical examination for postoperative complications (fistula, stenosis, )
Time frame: during follow-up visits at 1, 3, and 6 months post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Results publication: PubMed 35031224Abbas TO. Evaluation of penile curvature in patients with hypospadias; gaps in the current practice and future perspectives. J Pediatr Urol. 2022 Apr;18(2):151-159. doi: 10.1016/j.jpurol.2021.12.015. Epub 2021 Dec 31.
- Results publication: PubMed 35644790Abbas TO. An objective hypospadias classification system. J Pediatr Urol. 2022 Aug;18(4):481.e1-481.e8. doi: 10.1016/j.jpurol.2022.05.001. Epub 2022 May 11.
- Results publication: PubMed 39461004Elnashar AM, Albishbishy M, Sheir H, Elayyouti M, Elsherbiny M, Elzohiri M, Ghazaly Waly ME, Elsaied A. Comparative Study Between Autologous Platelet-rich Fibrin Membrane and Local Flaps as Intervening Layer in Management of Distal Hypospadias. J Pediatr Surg. 2025 Jan;60(1):161994. doi: 10.1016/j.jpedsurg.2024.161994. Epub 2024 Oct 11.
- 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 37740425Moraschini V, Miron RJ, Mourao CFAB, Louro RS, Sculean A, da Fonseca LAM, Calasans Maia MD, Shibli JA. Antimicrobial effect of platelet-rich fibrin: A systematic review of in vitro evidence-based studies. Periodontol 2000. 2024 Feb;94(1):131-142. doi: 10.1111/prd.12529. Epub 2023 Sep 22.
- 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 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: Undecided
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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.
Tariq Abbas, MD, PhD study chair
Sidra Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing - Group A: Platelet-rich fibrin membrane prepared intraoperatively and applied over neourethra and Group B: Ventral dartos flap rotated over neourethra in people with PRF and Hypospadias, 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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 1 Jul 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?
This study is still under way. Results are not available in the source record yet.
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?
Hypospadias Cosmetic Score (HOSE) (time frame: Follow-up evaluations will occur at 1, 3, and 6 months postoperatively.). 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 NCT07045545, which also lists 7 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 1 Jul 2025.