Efficacy of PRF in Hypospadias Repair

ConditionHypospadias
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age6-18
SponsorAin Shams University

About this 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.

Eligibility criteria

Qualifiers

Diagnosed with primary distal or mid-penile hypospadias.

Eligible for first-time (primary) surgical repair using the TIP (Tubularized Incised Plate) technique.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators