The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Healing of fissure
研究概览
简要总结
use of platelet rich plasma had good effect in treating chronic wounds. healing of perianal fissure could be prolonged and associated with pain. injection of platelet rich plasma under fissure base and edges had the advantage of improved fissure healing and reduction of the pain, with minimal side effects.
详细描述
Thirty milliliters of venous blood were withdrawn into eight syringes with preloaded 0.4 milliliters of anticoagulant (dextrose solution A) in each syringe to achieve concentration of 9:1.
The mixture centrifuged for 3000 round per minute for three minutes. After centrifugation separation of supernatant from the red blood cells, using three way-stopcock connector to collect the supernatant of all syringes into four new syringes that preloaded with 1 microgram of Prostaglandin E1 that diluted in normal saline (0.05 milliliters).
The four syringes centrifuge at 4000 round per minute for 15 minutes. The supernatant discarded using a three way-stopcock connector. The sediment mixed with vortex mixer (Vortex V-1 plus, BIOSAN).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic anal fissure for more than three months
排除标准
- •medical comorbidity
- •inflammatory bowel disease
- •tuberculosis fissure
- •HIV infected patients
研究组 & 干预措施
Nitroglycerin only
application of local Nitroglycerin ointment 2% (Recto-Relief Nitroglycerin Ointment, 30 g) applied twice daily.
干预措施: Nitroglycerin ointment (Drug)
platelet rich plasma injection
injection of platelet rich plasma under fissure base and edges
干预措施: Platelet rich plasma injection (Procedure)
platelet rich plasma injection
injection of platelet rich plasma under fissure base and edges
干预措施: Nitroglycerin ointment (Drug)
结局指标
主要结局
Healing of fissure
时间窗: 3 months
Complete epithelization of fissure base
次要结局
- Pain change(3 months)
- Duration of pain(3 months)