Effectiveness of Treatment With Rich Platelet Fibrin (PRF) VS Gold Standard in the Healing Process of Surgical Wounds in Patients Undergoing Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- clinical improvement of the healing process
研究概览
简要总结
Randomized controlled single blind trial for the evaluation of the treatment of the surgical wound healing process with Platelet-Rich-Fibrin compared to the gold standard (without Platelet-Rich-Fibrin) in patients undergoing knee replacement.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females undergoing a total knee prosthesis.
- •Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
- •Hb > 11 g/dl; Platelet value > 150.000 plt/mmc;
- •Patients with non clinical alteration of ECG;
- •Signature of informed consent;
排除标准
- •Patients incapable of understanding and of wanting;
- •Systemic disorders such as diabetes, rheumatic diseases;
- •Patients with malignancy;
- •Thyroid metabolic disorders ;
- •Abuse of alcohol, drugs and pharmaceutical drugs
- •Body mass index > 40;
研究组 & 干预措施
A
treatment of the surgical wound healing process with Platelet-rich-fibrin in patients undergoing total knee replacement surgery
干预措施: total knee replacement surgery (Procedure)
B
Gold standard treatment of the surgical wound healing process without Platelet-rich-fibrin in patients undergoing total knee replacement surgery
干预措施: total knee replacement surgery (Procedure)
结局指标
主要结局
clinical improvement of the healing process
时间窗: 2 weeks
Clinical improvement of the healing process, assessed by application of the Hollander Wound Evaluation Scales at 2 weeks of follow up
次要结局
- Dermatology life quality(3 days, 15 days and 1 month)