Ain Shams University
Cairo, Abbasia, 11517, Egypt
NCT Number: NCT07757828
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.
Trial opening soon.
Get Notified6 month–18 year
Male
Interventional
Not applicable
Cairo, Abbasia, 11517, Egypt
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: 6 months
Incidence of urethrocutaneous fistula formation
Time frame: 6 months
Parental satisfaction assessed using a standardized questionnaire HOPE score
Contact information is provided by the study sponsor or research team.
Mahmoud Mohamed Magdy El-Ansary, MSc
CONTACT
Younan R. Samir, M.D.
CONTACT
Ain Shams University
Other
Evaluating the Efficacy of Platelet-Rich Fibrin (PRF) in Hypospadias Repair: A Randomized Controlled Trial
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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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