HypospadiasNCT07757828
Efficacy of PRF in Hypospadias Repair
A study testing Tubularized Incised Plate urethroplasty with intraoperative placement of autologous PRF onto the urethral plate. and standard Tubularized Incised Plate urethroplasty in people with Hypospadias, run by Ain Shams University at 1 site in Egypt.
Trial summary
Hypospadias is an anomaly characterized by an ectopic ventral urethral meatus, and an incomplete or hooded prepuce. Its incidence is estimated at 1 in 200-300 live male births, with variations across populations and severity types. Read more about this study
- Who is it for?
- Ages 6 months to 18 years, men only
- Conditions the study is for
- Hypospadias
- What is being tested?
- Tubularized Incised Plate urethroplasty with intraoperative placement of autologous PRF onto the urethral plate. and standard Tubularized Incised Plate urethroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 1 Oct 2027
- 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 6 months to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with primary distal or mid-penile hypospadias.
- Eligible for first-time (primary) surgical repair using the TIP (Tubularized Incised Plate) technique.
Who cannot join
- previous hypospadias surgery.
- Associated severe chordee requiring staged repair or patient with crippled hypospadias.
- Children with systemic diseases that may impair wound healing (e.g., diabetes, immunodeficiency, malnutrition).
- Presence of bleeding or coagulation disorders.
- Medically Unfit for surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ain Shams University
Cairo, Abbasia, 11517
Younan R. Samir, M.D., +201201255511, dr_yona@live.com
About this study
Official title: Evaluating the Efficacy of Platelet-Rich Fibrin (PRF) in Hypospadias Repair: A Randomized Controlled Trial
Hypospadias is an anomaly characterized by an ectopic ventral urethral meatus, and an incomplete or hooded prepuce. Its incidence is estimated at 1 in 200-300 live male births, with variations across populations and severity types.
Successful hypospadias repair depends largely on optimal tissue healing and robust vascular support around the neourethra. Thus, many adjunctive techniques have been investigated to improve outcomes, including dartos flaps, tunica vaginalis flaps, and various tissue sealants.
Read more
In recent years, attention has turned toward biological augmentation strategies, particularly the use of platelet-rich plasma (PRP) and platelet-rich fibrin as a potential enhancer of wound healing.
Platelet-rich fibrin (PRF), a second-generation autologous platelet concentrate, has recently emerged as another promising biologic in tissue engineering.
This study aims to evaluate the effect of PRF application in primary hypospadias repair surgery and determine its effect in improving healing and reduction of postoperative complications.
Read the detailed description
All patients included in the study will undergo primary hypospadias repair using the standardized Tubularized Incised Plate (TIP) urethroplasty technique (Snodgrassi procedure), under general anesthesia and by the same surgical team to minimize variability
- Steps of the Surgical Procedure (Same for Both Groups):
- Preoperative preparation:
- IV antibiotics, sterile field setup, general anesthesia. 2. Urethral plate incision and tubularization over a 6-8 Fr stent using absorbable sutures.
- application of PRF (Group A only):
- 8-10 mL of autologous blood is drawn into plain (non-anticoagulant) tubes according to the patient's weight and the size of the patch needed.
- The sample is immediately centrifuged using the single-spin method (typically 3,000 rpm (400x g) for 12 minutes).
- This produces three layers:
- Top layer: acellular plasma (PPP)
- Middle layer: platelet-rich fibrin (PRF) clot
- Bottom layer: red blood cells The PRF clot is gently removed and compressed using a gauze to form a thin PRF membrane.
- PRF membrane is fixed on top of the suture line as a first layer and under the incision line as a second layer and secured using a few resorbable polyglyconate 6/0 interrupted sutures.
- Glansplasty and skin closure using standard techniques in both groups 5. Catheter and dressing:
- A soft catheter is left in place for 5-7 days.
- A mild compression dressing is applied.
- Conditions
- Hypospadias
- Being tested
- Tubularized Incised Plate urethroplasty with intraoperative placement of autologous PRF onto the urethral plate., standard Tubularized Incised Plate urethroplasty
- Keywords
- Hypospadias, PRF, Repair
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tubularized Incised Plate urethroplasty with intraoperative placement of autologous PRF onto the urethral plate.Procedure or surgery
Urethral plate incision and tubularization over a 6-8 Fr stent using absorbable sutures.
Application of PRF where 8-10 mL of autologous blood is drawn into plain (non-anticoagulant) tubes and a thin PRF membrane is extracted which is fixed on top of the suture line as a first layer and under the incision line as a second layer and secured using a few resorbable polyglyconate 6/0 interrupted sutures.
Glansplasty and skin closure using standard techniques and fixing catheter and dressing
standard Tubularized Incised Plate urethroplastyProcedure or surgery
Urethral plate incision and tubularization over a 6-8 Fr stent using absorbable sutures.
Glansplasty and skin closure using standard techniques and fixing catheter and dressing
| Study group | Role | What they receive |
|---|---|---|
| Group A TIP urethroplasty with autologous PRF | Experimental | Undergoes TIP urethroplasty with intraoperative placement of autologous PRF onto the urethral plate. Receives: Procedure: Tubularized Incised Plate urethroplasty with intraoperative placement of autologous PRF onto the urethral plate. |
| Group B standard TIP urethroplasty without PRF | Active comparator | Undergoes standard TIP urethroplasty without PRF application Receives: Procedure: standard Tubularized Incised Plate urethroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urethrocutaneous fistula formation
Incidence of urethrocutaneous fistula formation
Measured: 6 months
Parental satisfaction Assessment
Parental satisfaction assessed using a standardized questionnaire HOPE score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Model description
- All patients included in the study will undergo primary hypospadias repair using the standardized Tubularized Incised Plate (TIP) urethroplasty technique (Snodgrassi procedure), under general anesthesia and by the same surgical team to minimize variability
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younan Ramsis, Ain Shams University
- Investigators
- Hany H. Gad, Professor, Study chair, Ain Shams UniversityHossam M.H. ElAwady, Professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757828
- Sponsor's protocol ID
- PRF Hypospaias 001
- Status last verified
- Aug 2026
- First submitted
- 26 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eryilmaz R, Simsek M, Aslan R, Beger B, Ertas K, Taken K. The effect of plasma rich platelet graft on post-operative complications in mid-penile hypospadias. Andrologia. 2020 Aug;52(7):e13652. doi: 10.1111/and.13652. Epub 2020 May 20.
PubMed 32436309
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Platelet-Rich Fibrin (PRF) in Hypospadias Repair: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07757828
- Acronym / sponsor ID
- PRF Hypospaias 001
- Conditions
- Hypospadias
- Keywords
- Hypospadias, PRF, Repair
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 11 Aug 2026 (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.
Hypospadias is an anomaly characterized by an ectopic ventral urethral meatus, and an incomplete or hooded prepuce. Its incidence is estimated at 1 in 200-300 live male births, with variations across populations and severity types.
Successful hypospadias repair depends largely on optimal tissue healing and robust vascular support around the neourethra. Thus, many adjunctive techniques have been investigated to improve outcomes, including dartos flaps, tunica vaginalis flaps, and various tissue sealants.
In recent years, attention has turned toward biological augmentation strategies, particularly the use of platelet-rich plasma (PRP) and platelet-rich fibrin as a potential enhancer of wound healing.
Platelet-rich fibrin (PRF), a second-generation autologous platelet concentrate, has recently emerged as another promising biologic in tissue engineering.
This study aims to evaluate the effect of PRF application in primary hypospadias repair surgery and determine its effect in improving healing and reduction of postoperative complications.
Detailed description
All patients included in the study will undergo primary hypospadias repair using the standardized Tubularized Incised Plate (TIP) urethroplasty technique (Snodgrassi procedure), under general anesthesia and by the same surgical team to minimize variability
- Steps of the Surgical Procedure (Same for Both Groups):
- Preoperative preparation:
- IV antibiotics, sterile field setup, general anesthesia. 2. Urethral plate incision and tubularization over a 6-8 Fr stent using absorbable sutures.
- application of PRF (Group A only):
- 8-10 mL of autologous blood is drawn into plain (non-anticoagulant) tubes according to the patient's weight and the size of the patch needed.
- The sample is immediately centrifuged using the single-spin method (typically 3,000 rpm (400x g) for 12 minutes).
- This produces three layers:
- Top layer: acellular plasma (PPP)
- Middle layer: platelet-rich fibrin (PRF) clot
- Bottom layer: red blood cells The PRF clot is gently removed and compressed using a gauze to form a thin PRF membrane.
- PRF membrane is fixed on top of the suture line as a first layer and under the incision line as a second layer and secured using a few resorbable polyglyconate 6/0 interrupted sutures.
- Glansplasty and skin closure using standard techniques in both groups 5. Catheter and dressing:
- A soft catheter is left in place for 5-7 days.
- A mild compression dressing is applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All patients included in the study will undergo primary hypospadias repair using the standardized Tubularized Incised Plate (TIP) urethroplasty technique (Snodgrassi procedure), under general anesthesia and by the same surgical team to minimize variability
| Arm | Type | Receives |
|---|---|---|
| Group A TIP urethroplasty with autologous PRF | Experimental | Procedure: Tubularized Incised Plate urethroplasty with intraoperative placement of autologous PRF onto the urethral plate.Undergoes TIP urethroplasty with intraoperative placement of autologous PRF onto the urethral plate. |
| Group B standard TIP urethroplasty without PRF | Active comparator | Procedure: standard Tubularized Incised Plate urethroplastyUndergoes standard TIP urethroplasty without PRF application |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosed with primary distal or mid-penile hypospadias.
- Eligible for first-time (primary) surgical repair using the TIP (Tubularized Incised Plate) technique.
Key exclusion criteria (5 listed)
- previous hypospadias surgery.
- Associated severe chordee requiring staged repair or patient with crippled hypospadias.
- Children with systemic diseases that may impair wound healing (e.g., diabetes, immunodeficiency, malnutrition).
- Presence of bleeding or coagulation disorders.
- Medically Unfit for surgery.
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 |
|---|---|---|
| Tubularized Incised Plate urethroplasty with intraoperative placement of autologous PRF onto the urethral plate.Urethral plate incision and tubularization over a 6-8 Fr stent using absorbable sutures. Application of PRF where 8-10 mL of autologous blood is drawn into plain (non-anticoagulant) tubes and a thin PRF membrane is extracted which is fixed on top of the suture line as a first layer and under the incision line as a second layer and secured using a few resorbable polyglyconate 6/0 interrupted sutures. Glansplasty and skin closure using standard techniques and fixing catheter and dressing | Procedure or surgery | Group A TIP urethroplasty with autologous PRF |
| standard Tubularized Incised Plate urethroplastyUrethral plate incision and tubularization over a 6-8 Fr stent using absorbable sutures. Glansplasty and skin closure using standard techniques and fixing catheter and dressing | Procedure or surgery | Group B standard TIP urethroplasty without PRF |
Primary outcome
Urethrocutaneous fistula formation
Time frame: 6 months
Incidence of urethrocutaneous fistula formation
Parental satisfaction Assessment
Time frame: 6 months
Parental satisfaction assessed using a standardized questionnaire HOPE score
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 11 Aug 2026.
- Background: PubMed 32436309Eryilmaz R, Simsek M, Aslan R, Beger B, Ertas K, Taken K. The effect of plasma rich platelet graft on post-operative complications in mid-penile hypospadias. Andrologia. 2020 Aug;52(7):e13652. doi: 10.1111/and.13652. Epub 2020 May 20.
- Individual participant dataSharing planned: No
Related trials for Hypospadias
Not yet recruitingPhase 4
Effect of Oxybutynin on Opioid Use After Urologic Surgery in Children
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Recruiting
Worldwide Yearly Screening for Hypospadias
Hypospadias
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Active, not recruiting
Evaluating the Efficacy and Safety of Tranexamic Acid in Reducing Perioperative Bleeding During Recurrent Hypospadias Repair.
Perioperative Bleeding During Recurrent Hypospadias Repair
Enrolling by invitation
Genetics of Differences of Sex Development and Hypospadias
Disorders of Sex Development, Hypospadias
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.
Hany H. Gad, Professor study chair
Ain Shams University
Hossam M.H. ElAwady, Professor study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tubularized Incised Plate urethroplasty with intraoperative placement of autologous PRF onto the urethral plate. and standard Tubularized Incised Plate urethroplasty in people with Hypospadias, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 11 Aug 2026. 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 Egypt. 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?
Contact Mahmoud Mohamed Magdy El-Ansary, MSc (+201114393349, mahmoudmagdy99@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urethrocutaneous fistula formation (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT07757828, which also lists 1 linked publication.
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 11 Aug 2026.