A Study Evaluating Intraoperative Application of Platelet-Rich Plasma to the Neurovascular Bundles During Nerve-Sparing Radical Prostatectomy: Initial Technical Description and Prospective Early Postoperative Outcomes Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB)
研究概览
简要总结
Can platelet rich plasma applied to nerve bundles at time of surgery help the nerve bundles heal? Subjects undergoing a Radical Prostatectomy who meet study inclusion/exclusion criteria will be consented to receive an intraoperative application of platelet-rich plasma, made from their own blood at the time of surgery, for application onto their neurovascular bundles in an effort to improve the healing process. Subjects will be followed for an additional 18 months to determine the efficacy and safety of this procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed, clinically localized prostatic adenocarcinoma
- •Age 50 - 60 years
- •Male gender
- •Normal preoperative sexual function
- •Normal urinary continence
排除标准
- •Unable or unwilling to provide informed consent
- •Vulnerable study populations
- •Active systemic infection
- •Diabetes mellitus diagnosis
- •Preexisting Erectile Dysfunction or urinary incontinence
- •Metastatic or locally advanced prostatic adenocarcinoma on preoperative evaluation
- •Men found grossly or pathologically to have locally advanced or metastatic disease at the time of radical prostatectomy
- •An estimated blood loss of > 750 mL at the time of radical prostatectomy
- •Treatment prior to surgery with any form of hormones, anti-androgens or androgen deprivation therapy
- •Use of an antidepressant, beta blocker or erectile dysfunction medication at the time of study screening
- •Men without a regular sexual partner
- •Use of aspirin or heparin 2 weeks before radical prostatectomy
- •Need for use of aspirin or heparin for 2 weeks or more after radical prostatectomy
结局指标
主要结局
Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB)
时间窗: 18 months
Assessed by the number of subjects experiencing serious adverse events (SAEs) after treatment with PRP following nerve-sparing radical prostatectomy
次要结局
- Change in Sexual Function Using International Index of Erectile Function (IIEF-5)(Baseline; every 3 months up to 18 months.)
- Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC)(Baseline; 3 months; 6 months; 9 months; 12 months; 18 months)