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Efficacy of PRF in Hypospadias Repair

NCT07757828 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-08-11

No results posted yet for this study

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

Interventions

PROCEDURE

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

standard Tubularized Incised Plate urethroplasty

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

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Hany H. Gad, Professor · Ain Shams University

  • Hossam M.H. ElAwady, Professor · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-08-01
Completion
2027-10-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07757828 on ClinicalTrials.gov