跳至主要内容
临床试验/CTRI/2024/07/069879
CTRI/2024/07/069879尚未招募2 期

Use of Platelet Rich Plasma Gel in preventing healing complications of Tubularised Incised Plate Urethroplasty in Children with distal and mid-penile hypospadias

Shreyas Dudhani1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
82
试验地点
1
主要终点
Post Operative Urethrocutaneous Fistula formation

研究概览

简要总结

Hypospadias is a fairly common congenital disorder of the male external genitalia. It leads to an abnormally positioned urethral meatus on the underside of the penis and is associated with downward bending of penis and deficient foreskin. It is surgically repaired in multiple ways with each repair having its own complications. Complete or partial failure of the repair can occur in the form of urethrocutaneous fistula, glans dehiscence, urethral or meatal stenosis and stricture urethra. These complications can often be prevented with a good layered closure of the urethra which ensures adequate blood supply and healing of tissue.

Platelet rich plasma gel is a platelet concentrate formed by centrifugation of whole blood. It has been shown to promote wound healing. Hence it would be ideal to use something that improves vascularity and tissue growth.

We expect a decreased proportion of complications (urethrocutaneous fistula) in the group in which PRP gel is used. The post operative HOSE(Hypospadias Objective Scoring Evaluation) is expected to be better in the study group. Patients with fewer complications will require fewer hospital visits and fewer surgeries

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
0.00 Day(s) 至 14.00 Year(s)(—)
性别
Male

入选标准

  • Primary Hypospadias Distal and Mid Penile Hypospadias.

排除标准

  • Redo Surgery Associated with Undescended testis, major system anomaly Bleeding Disorder, Thrombocytopenia All Other Varieties of Hypospadias (Severe).

结局指标

主要结局

Post Operative Urethrocutaneous Fistula formation

时间窗: 1 and 3 months post surgery

次要结局

  • Post Operative Wound Infection,(Post Operative Glans Dehiscence,)

研究者

发起方
Shreyas Dudhani
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Shreyas Dudhani

All India Institute of Medical Sciences, Patna

研究点 (1)

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