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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Group A TIP urethroplasty with autologous PRFExperimental treatment 1 intervention

Group B: Group B standard TIP urethroplasty without PRFActive comparator 1 intervention

Trial outcomes

Primary outcomes

Urethrocutaneous fistula formation

Incidence of urethrocutaneous fistula formation

Time frame

6 months

Parental satisfaction Assessment

Parental satisfaction assessed using a standardized questionnaire HOPE score

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov

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