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临床试验/NCT06748573
NCT06748573已完成不适用

A Prospective Study of a Novel Pocket Compression Device to Reduce Pocket Hematoma After Cardiac Implantable Electronic Device Implantation in a High Bleeding Risk Population

Maxime Tijskens1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
pocket hematome

研究概览

简要总结

Your doctor has determined that you have an indication for cardiac implantation implantable electronic device (CIED = collective name for pacemaker or defibrillator). Pocket bleeding is a possible complication that occurs in 0.2-16% of cases depending on the definition used. They are an important risk factor for CIED infections (factor 9x). Other possible consequences include prolonged hospitalization risk of stroke due to discontinuation of blood thinners and even death. The main known risk factors for pocket bleeding are advanced age, heart failure, kidney failure, congenital bleeding tendency and the use of blood thinners. Have several measures to reduce the risk of pocket bleeding varying or limited effects shown in the past. Currently the standard treatment consists of applying a conventional pressure bandage at the pocket.However, the lack of targeted compression and lack of standardization has caused this only a limited effect and contributes to patient discomfort. Moreover, let a Conventional pressure dressing does not allow the pocket to be evaluated. The SafeGuard FocusTM compression bandage is a promising new option with several technical features advantages: it can deliver 2x as much pressure as a conventional pressure bandage, the amount pressure can be adjusted according to effect and patient comfort and there is a transparent window so that the surgical wound can always be inspected. This new pressure bandages already used in several countries, but has never been compared until now with a conventional pressure bandage.

详细描述

Prospective study on the potential benefit of SafeGuard FocusTM compression dressing in preventing pocket bleeding after implantation of a cardiac implantable electrical device in patients with an increased risk of bleeding Introduction You are invited to participate in a research study involving up to 200 patients . The study aims to confirm the effectiveness and safety of the SafeGuard FocusTM compression bandage when compared to the conventional compression bandage. Your participation in the study will last a total of 1 month and will take place during the standard follow-up moments on the day of implantation, the next day and the first check-up after 1 month. So no additional follow-up moments are required. Before you agree to participate in this study, please consider how the study is designed and the potential risks and benefits so that you can make an informed decision. This process is called 'giving consent'.

The implantation procedure is identical in both groups, only the type of pressure bandage applied after the procedure is different.

SafeGuard FocusTM compression bandage:

If randomized to the study group, the SafeGuard FocusTM pressure bandage will be applied immediately after closing the skin according to the following steps:

Preparation: Clean and dry wound and surrounding skin Placement: Apply isobetadine gauze and transparent bandage. Apply SafeGuard FocusTM pressure bandage with balloon placed at CIED pocket.

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
None

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 undergoing primo CIED implantation (pacemaker, internal cardiac defibrillator or cardiac resynchronization therapy)
  • •with a high bleeding risk (as defined by at least 1 of the following risk factors: age > 75 years, heart failure, kidney failure, antithrombotic use (double antiaggregant therapy or anticoagulation

排除标准

  • •refusal to participate
  • •mental illness

研究组 & 干预措施

Control arm

Active Comparator

conventional compression bandage

干预措施: Conventional bandage (Device)

Study arm

Experimental

Study device (inflatable and see-through)

干预措施: SafeGuard FocusTM compression bandage (Device)

结局指标

主要结局

pocket hematome

时间窗: 24 hours

Grade I PH is defined as pocket ecchymosis or small effusion in the absence of swelling or pain. Grade II PH consists of large pocket effusion leading to swelling or pain. Grade III PH is characterized by the need of reoperation and/or hospitalization prolongation and/or interruption of antithrombotic drugs.

次要结局

  • pain score(24 hours)

研究者

发起方
Maxime Tijskens
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Maxime Tijskens

Principal investigator

Ziekenhuis aan de Stroom

研究点 (1)

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