NCT05189392尚未招募不适用
Effect of PICO Compared to Opsite Post-Op Visible on Surgical Wound in Patients at High Risk of Local Complications, Undergoing Hip Arthroplasty
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年1月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- By ultrasound examination at 7 +/- 1 days after hip replacement surgery, underestimating the effect of PICO compared to Opsite Post-Op Visible in the 70% reduction of post-surgical hematoma formation
研究概览
简要总结
Evaluate the effect of the PICO medical device, compared to the Opsite Post-Op Visible medical device, in reducing the formation of postsurgical hematoma in the surgical wound of patients at high risk of local complications, undergoing hip arthroplasty
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
- None
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 55 and 85 years inclusive,
- •Patients with BMI ≥ 30 + ASA 3 + Diabetes mellitus
- •Patients suffering from coxarthrosis candidates for hip arthroplasty surgery or revision of hip arthroplasty
排除标准
- •Age> 85 years, <55 years
- •Patients who are unable to understand and want.
- •Patients with severe neurological disorders or with severe disabilities.
- •Oncological patients and patients with malignant tumor at the edge of the wound
- •Patients who have undergone radiotherapy treatment
- •Patients with bleeding disorders
- •Patients on anticoagulant treatment with warfarin or NAO
- •Previously confirmed osteomyelitis
- •Patients with liver cirrhosis
- •Patients with non-enteric fistulas
- •Patients with necrotic tissue with the presence of eschar at the intervention site
- •Patients with autoimmune thrombocytopenia.
结局指标
主要结局
By ultrasound examination at 7 +/- 1 days after hip replacement surgery, underestimating the effect of PICO compared to Opsite Post-Op Visible in the 70% reduction of post-surgical hematoma formation
时间窗: 8 day
By ultrasound examination at 7 +/- 1 days after hip replacement surgery, underestimating the effect of PICO compared to Opsite Post-Op Visible in the 70% reduction of post-surgical hematoma formation
次要结局
未报告次要终点
研究者
研究点 (2)
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