Evaluating the Efficacy of Platelet-Rich Fibrin (PRF) in Hypospadias Repair: A Randomized Controlled Trial
| Registry | NCT07757828 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 80 (Estimated) |
| Sponsor | Ain Shams University (Other) |
| Conditions | Hypospadias |
| Interventions | Tubularized Incised Plate urethroplasty with intraoperative placement of autologous PRF onto the urethral plate., standard Tubularized Incised Plate urethroplasty (Procedure) |
| Dates | start 2026-08-01 (estimated), primary completion 2027-08-01 (estimated), completion 2027-10-01 (estimated), first posted 2026-08-11, last updated 2026-08-11 |
| Locations | 1 site in Egypt |
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All trials for Hypospadias All trials of Tubularized Incised Plate urethroplasty with intraoperative placement of autologous PRF onto the urethral plate. All trials of standard Tubularized Incised Plate urethroplasty
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):
* 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.
4\. 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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group A TIP urethroplasty with autologous PRF | Experimental | Procedure: Tubularized Incised Plate urethroplasty with intraoperative placement of autologous PRF onto the urethral plate. | Undergoes TIP urethroplasty with intraoperative placement of autologous PRF onto the urethral plate. |
| Group B standard TIP urethroplasty without PRF | Active comparator | Procedure: standard Tubularized Incised Plate urethroplasty | Undergoes standard TIP urethroplasty without PRF application |
Sex: Male, ages: 6 Months to 18 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Ain Shams University | Cairo, Abbasia | Egypt |