About this trial
Hypospadias is a common congenital condition in boys in which the opening of the urethra is located on the underside of the penis. Distal hypospadias is the most common form and is usually treated surgically using tubularized incised plate (TIP) urethroplasty. In boys with an unfavorable urethral plate, graft-augmented techniques (G-TIP) are often used; however, postoperative complications such as urethrocutaneous fistula and narrowing of the urethral opening (meatal stenosis) may still occur.
Platelet-rich fibrin (PRF) is a biological material obtained from the patient's own blood that contains natural growth factors and may help improve tissue healing. This study aims to evaluate whether the use of PRF during surgery can reduce postoperative complications and improve surgical outcomes in children undergoing hypospadias repair.
Eligibility criteria
Qualifiers
Male children aged 6 months to 84 months
Primary or redo distal hypospadias
Unfavorable urethral plate
Penile curvature less than 45 degrees after degloving
Disqualifiers
Disorders of sex development or ambiguous genitalia
Severe penile curvature requiring urethral plate transection
Previous graft-based urethroplasty
Active local or systemic infection at the time of surgery
Trial design
Treatments tested in this trial
- Fibrin-Enhanced TIP Urethroplasty
- Grafted TIP Urethroplasty
Treatment groups
Sponsors and collaborators
National Children's Medical Center, Uzbekistan
Lead sponsor
Dr Cipto Mangunkusumo General Hospital
Collaborator