Use of Platelet-Rich Fibrin in Bladder Exstrophy Repair: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of Penopubic Fistula
研究概览
简要总结
Bladder exstrophy-epispadias complex (BEEC) is a rare condition in which the bladder and surrounding structures do not form normally. Surgery is required to close the bladder and restore normal anatomy, but complications such as penopubic fistula and wound breakdown are common after repair. Platelet-rich fibrin (PRF) is a material obtained from a patient's own blood that contains healing factors and may improve wound healing.
This prospective randomized controlled study evaluates whether applying autologous PRF during primary bladder exstrophy repair can reduce postoperative complications compared with standard surgical closure alone. Twenty pediatric patients with primary BEEC undergoing surgical repair were randomly assigned to either a PRF group or a non-PRF (control) group. The main outcome measured was the occurrence of penopubic fistula after surgery, along with other postoperative complications. The results of this study aim to help determine whether PRF is a safe and effective adjunct in bladder exstrophy repair.
详细描述
This is a single-center, prospective, randomized controlled clinical trial conducted in the Pediatric Urology Department of the National Children's Medical Center between 2022 and 2025. The study enrolled 20 male patients with primary bladder exstrophy-epispadias complex undergoing initial surgical repair. Patients with cloacal variants and complicated cases were excluded.
Participants were randomly allocated using a computer-generated random number sequence into two groups: the PRF group (n = 12), in which autologous platelet-rich fibrin was applied during bladder neck repair, and the non-PRF control group (n = 8), in which standard wound closure was performed without PRF.
In the PRF group, 5-10 mL of venous blood was collected intraoperatively and centrifuged to prepare a PRF membrane, which was applied over the bladder neck before pubic symphysis closure. Both groups underwent standardized surgical repair techniques, including complete primary repair or modified staged repair as indicated.
The primary outcome was the incidence of penopubic fistula formation. Secondary outcomes included wound dehiscence, hospital stay, and postoperative complications. Patients were followed postoperatively according to the institutional protocol.
This study was approved by the Institutional Review Board of the National Children's Medical Center (Approval No.: 052022/14), and informed consent was obtained from the parents or legal guardians of all participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Male patients diagnosed with primary bladder exstrophy-epispadias complex (BEEC)
- •Age from birth up to 18 years
- •Patients undergoing primary surgical repair of bladder exstrophy
- •Written informed consent provided by parents or legal guardians
排除标准
- •Patients with cloacal variants of bladder exstrophy
- •Patients with complicated or recurrent bladder exstrophy
- •Patients who previously underwent bladder exstrophy repair
- •Patients with severe associated congenital anomalies that could affect wound healing
- •Patients with coagulation abnormalities
- •Patients with severe anemia
研究组 & 干预措施
PRF Group
Participants undergo primary bladder exstrophy repair with intraoperative application of autologous platelet-rich fibrin over the bladder neck before pubic symphysis closure.
干预措施: Autologous Platelet-Rich Fibrin (Biological)
Non-PRF Group
Participants undergo standard primary bladder exstrophy repair without the use of platelet-rich fibrin.
干预措施: Standard Surgical Closure (Procedure)
结局指标
主要结局
Incidence of Penopubic Fistula
时间窗: from 3 month to 6 month
Occurrence of clinically confirmed penopubic fistula following primary bladder exstrophy repair in the PRF and non-PRF groups.
次要结局
- Incidence of Wound Dehiscence(Within 6 months after surgery)
研究者
Zafar Abdullaev
Head of Pediatric urology department
National Children's Medical Center, Uzbekistan