An interventional study of Tubularized Incised Plate urethroplasty with intraoperative placement of autologous PRF onto the urethral plate. and standard Tubularized Incised Plate urethroplasty in Hypospadias, sponsored by Ain Shams University. Not yet recruiting at 1 site in Egypt. Open to male participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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.
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):
1. Preoperative preparation:
IV antibiotics, sterile field setup, general anesthesia. 2. Urethral plate incision and tubularization over a 6-8 Fr stent using absorbable sutures.
3. application of PRF (Group A only):
This produces three layers:
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.
4. Glansplasty and skin closure using standard techniques in both groups 5. Catheter and dressing:
123 studies on the registry are indexed under Hypospadias; 34 are open to participants now.
This study's planned enrollment of 80 is above the median of 70 across 97 interventional studies indexed under Hypospadias.
Browse Hypospadias studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Undergoes TIP urethroplasty with intraoperative placement of autologous PRF onto the urethral plate.
Procedure: Tubularized Incised Plate urethroplasty with intraoperative placement of autologous PRF onto the urethral plate.
Undergoes standard TIP urethroplasty without PRF application
Procedure: standard Tubularized Incised Plate urethroplasty
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
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
Plan to share: No
Start is estimated for Aug 2026; primary completion for Aug 2027, 12 months later.
Of 60 non-industry interventional studies with no phase under Hypospadias, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 39. This study's planned 12 months is below that.
Counting every sponsor, half of 60 studies reached it within 15 months; a quarter within 8 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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