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Efficacy of PRF in Hypospadias Repair

2026年8月10日 更新者：Younan Ramsis、Ain Shams University

Evaluating the Efficacy of Platelet-Rich Fibrin (PRF) in Hypospadias Repair: A Randomized Controlled Trial

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Younan R. Samir, M.D.
  • 电话号码：+201201255511
  • 邮箱：dr_yona@live.com

学习地点

  • 埃及
    • Abbasia
      • Cairo、Abbasia、埃及、11517
        • Ain Shams University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Group A TIP urethroplasty with autologous PRF
Undergoes TIP urethroplasty with intraoperative placement of autologous PRF onto the urethral plate.
程序：Tubularized Incised Plate urethroplasty with intraoperative placement of autologous PRF onto the urethral plate.

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
有源比较器：Group B standard TIP urethroplasty without PRF
Undergoes standard TIP urethroplasty without PRF application
程序：standard Tubularized Incised Plate urethroplasty

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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Urethrocutaneous fistula formation
大体时间：6 months
Incidence of urethrocutaneous fistula formation
6 months
Parental satisfaction Assessment
大体时间：6 months
Parental satisfaction assessed using a standardized questionnaire HOPE score
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ain Shams University

调查人员

  • 学习椅：Hany H. Gad, Professor、Ain Shams University
  • 研究主任：Hossam M.H. ElAwady, Professor、Ain Shams University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年10月1日

研究注册日期

首次提交

2026年7月26日

首先提交符合 QC 标准的

2026年8月10日

首次发布 (实际的)

2026年8月11日

研究记录更新

最后更新发布 (实际的)

2026年8月11日

上次提交的符合 QC 标准的更新

2026年8月10日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PRF Hypospaias 001

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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