Efficacy of PRF in Hypospadias Repair

NCT07757828 | Not Yet Recruiting DMC

• 1 other identifier: PRF Hypospaias 001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypospadias

Keywords

Hypospadias; PRF; Repair

Outcome Measures

Primary Outcomes (2)

• Urethrocutaneous fistula formation

  Incidence of urethrocutaneous fistula formation

  6 months

• Parental satisfaction Assessment

  Parental satisfaction assessed using a standardized questionnaire HOPE score

  6 months

Study Arms (2)

Group A TIP urethroplasty with autologous PRF

EXPERIMENTAL

Undergoes TIP urethroplasty with intraoperative placement of autologous PRF onto the urethral plate.

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

Procedure: standard Tubularized Incised Plate urethroplasty

Interventions

Tubularized Incised Plate urethroplasty with intraoperative placement of autologous PRF onto the urethral plate. PROCEDURE

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

Group A TIP urethroplasty with autologous PRF

standard Tubularized Incised Plate urethroplasty PROCEDURE

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

Group B standard TIP urethroplasty without PRF

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed with primary distal or mid-penile hypospadias.
• Eligible for first-time (primary) surgical repair using the TIP (Tubularized Incised Plate) technique.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbasia, 11517, Egypt

Location

Related Publications (1)

• 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.

  PMID: 32436309 BACKGROUND

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Hany H. Gad, Professor

  Ain Shams University

  STUDY CHAIR

• Hossam M.H. ElAwady, Professor

  Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Mahmoud Mohamed Magdy El-Ansary, MSc

CONTACT

+201114393349; mahmoudmagdy99@hotmail.com

Younan R. Samir, M.D.

CONTACT

+201201255511; dr_yona@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of urology

Model Details: 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

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: August 11, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)