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NCT Number: NCT07757828

Efficacy of PRF in Hypospadias Repair

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.

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Key information

Age range

6 month–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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):
  • Preoperative preparation:
  • IV antibiotics, sterile field setup, general anesthesia. 2. Urethral plate incision and tubularization over a 6-8 Fr stent using absorbable sutures.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Urethrocutaneous fistula formation

    Time frame: 6 months

    Incidence of urethrocutaneous fistula formation

  2. Parental satisfaction Assessment

    Time frame: 6 months

    Parental satisfaction assessed using a standardized questionnaire HOPE score

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Mohamed Magdy El-Ansary, MSc

CONTACT

[email protected]

+201114393349

Younan R. Samir, M.D.

CONTACT

[email protected]

+201201255511

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Evaluating the Efficacy of Platelet-Rich Fibrin (PRF) in Hypospadias Repair: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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