Efficacy of the hYpothermic Compression Bandage in the Surgical Wound of Cardiac Devices: A RAndomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Appearance of hematoma
研究概览
简要总结
The aim of this study is to evaluate the efficacy of hypothermic compression bandaging versus conventional compression bandaging, for the prevention of surgical wound hematoma of cardiac implementable electronic devices in patients undergoing chronic oral anticoagulant therapy and/or oral antiplatelet therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients under oral anticoagulation and/or antiplatelet treatment who were going to undergo implantation of an implanted device cardiac stimulation or generator replacement due to battery depletion
排除标准
- •insertion of drainage in the wound,
- •non-compliance with the pre-surgical antithrombotic protocol
- •INR in a high therapeutic range (>3.5)
- •Do not follow-up in the same hospital
- •Coagulation and hemostasis disorders
- •Replacement of devices due to alterations in the operation unrelated to the battery.
研究组 & 干预措施
hypothermic compression bandage
干预措施: hypothermic compression bandage (Procedure)
Conventional compression bandage
干预措施: Conventional compression bandage (Procedure)
结局指标
主要结局
Appearance of hematoma
时间窗: 10 days
Classification of pocket hematoma according to DeSensi et al.: Grade I: ecchymosis, defined as minor bleeding in the cardiac device pocket, no swelling or pain (watch and wait). Grade II: medium hematoma described as a palpable, bulging mass of \<2cm over the implanted generator. Moderate bleeding in the pocket of the MCP or ICD, causing functional impairment or pain in the area of the heart device Grade III: severe hematoma Determined as a palpable, bulging mass \>2cm. Evacuation is required if it causes tension in the skin with poor tissue perfusion, which is increasing and generates severe pain. Prolongs the patient's hospitalization or readmission for more than 24 hours. Requires immediate discontinuation of OACs or oral antiplatelets
次要结局
- Appearance of severe hematoma(10 days)
研究者
Josep Lluis Mont Girbau
Head of Arrythmia Unit
Hospital Clinic of Barcelona