Evaluating the Efficacy of Platelet-Rich Fibrin (PRF) in Hypospadias Repair: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Urethrocutaneous fistula formation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with primary distal or mid-penile hypospadias.
- •Eligible for first-time (primary) surgical repair using the TIP (Tubularized Incised Plate) technique.
排除标准
- •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.
研究组 & 干预措施
Group B standard TIP urethroplasty without PRF
Undergoes standard TIP urethroplasty without PRF application
干预措施: standard Tubularized Incised Plate urethroplasty (Procedure)
Group A TIP urethroplasty with autologous PRF
Undergoes TIP urethroplasty with intraoperative placement of autologous PRF onto the urethral plate.
干预措施: Tubularized Incised Plate urethroplasty with intraoperative placement of autologous PRF onto the urethral plate. (Procedure)
结局指标
主要结局
Urethrocutaneous fistula formation
时间窗: 6 months
Incidence of urethrocutaneous fistula formation
Parental satisfaction Assessment
时间窗: 6 months
Parental satisfaction assessed using a standardized questionnaire HOPE score
次要结局
未报告次要终点
研究者
Younan Ramsis
Lecturer of urology
Ain Shams University