Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Anterior wall descensus measured by the POP-Q System, Ba point
研究概览
简要总结
The purpose of the study is to evaluate the surgical outcomes of injecting platelet-rich plasma (PRP) into the vaginal tissue as an adjunct therapy at the time of prolapse surgery
详细描述
Platelet rich plasma (PRP) is an autologous product with high levels of platelets which are concentrated with bioactive growth factors responsible for accelerating tissue healing by stimulating the number of reparative cells to create collagen production, angiogenesis and neurogenesis. The overarching goal is to evaluate the effectiveness and safety of the adjunct application of PRP in the fibromuscular connective tissue (the site of anterior tissue plication) at the time of anterior colporrhaphy (the site of highest recurrence risk) in women undergoing native tissue vaginal prolapse repair, to promote tissue healing and regeneration, thus to improve surgical outcomes.
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
- Double (Participant, Care Provider)
盲法说明
Masking: Participants and study examiners performing the postoperative assessment will remain masked to the intervention assignment for the study duration, unless a medical indication for unmasking is identified.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Desire surgical treatment via a transvaginal native tissue approach.
- •Completed child-bearing
排除标准
- •Unable to follow-up, not willing to, or unable to participate in the proposed study
- •Prior pelvic surgery within the past 12 months
- •Prior anterior/apical suspension procedures
- •Prior graft augmented prolapse surgery
- •Pelvic/abdominal radiation
- •Pelvic mass
- •History of solid organ malignancy
研究组 & 干预措施
Adjunct Platelet rich plasma (PRP) therapy
Study Interventions: PRP will be injected in a systematic grid like fashion into the fibromuscular connective tissue of the anterior compartment following vaginal incision and dissection.
干预措施: Platelet rich plasma (PRP) Injection (Procedure)
Normal saline
Placebo: Normal saline will be injected in a systematic grid like fashion into the fibromuscular connective tissue of the anterior compartment following vaginal incision and dissection.
干预措施: Placebo (Procedure)
结局指标
主要结局
Anterior wall descensus measured by the POP-Q System, Ba point
时间窗: 12 month
Anterior wall descensus measured by the POP-Q System, Ba point
次要结局
- Apical wall descensus measured by the POP-Q System, C point(12 months)
- Safety outcomes(12 months)
- Retreatment(12 months)
- Leading edge(12 months)
- Posterior wall descensus(12 months)
- Subjective(12 months)
研究者
Isuzu Meyer
Associate Professor
University of Alabama at Birmingham