Efficacy of PRF in Hypospadias Repair
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.
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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):
1. Preoperative preparation:
IV antibiotics, sterile field setup, general anesthesia. 2. Urethral plate incision and tubularization over a 6-8 Fr stent using absorbable sutures.
3. 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.
4. 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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mahmoud Mohamed Magdy El-Ansary, MSc
- Número de teléfono: +201114393349
- Correo electrónico: mahmoudmagdy99@hotmail.com
Copia de seguridad de contactos de estudio
- Nombre: Younan R. Samir, M.D.
- Número de teléfono: +201201255511
- Correo electrónico: dr_yona@live.com
Ubicaciones de estudio
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Abbasia
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Cairo, Abbasia, Egipto, 11517
- Ain Shams University
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Contacto:
- Younan R. Samir, M.D.
- Número de teléfono: +201201255511
- Correo electrónico: dr_yona@live.com
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Diagnosed with primary distal or mid-penile hypospadias.
- Eligible for first-time (primary) surgical repair using the TIP (Tubularized Incised Plate) technique.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group A TIP urethroplasty with autologous PRF
Undergoes TIP 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 |
|
Comparador activo: Group B standard TIP urethroplasty without PRF
Undergoes standard TIP urethroplasty without PRF application
|
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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Urethrocutaneous fistula formation
Periodo de tiempo: 6 months
|
Incidence of urethrocutaneous fistula formation
|
6 months
|
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Parental satisfaction Assessment
Periodo de tiempo: 6 months
|
Parental satisfaction assessed using a standardized questionnaire HOPE score
|
6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Hany H. Gad, Professor, Ain Shams University
- Director de estudio: Hossam M.H. ElAwady, Professor, Ain Shams University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades Genitales Masculinas
- Enfermedades urogenitales masculinas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Anomalías congénitas
- Anomalías urogenitales
- Enfermedades del pene
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Hipospadias
Otros números de identificación del estudio
- PRF Hypospaias 001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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