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临床试验/NCT04389398
NCT04389398Unknown不适用

A Randomized, Controlled Study of Preventing Effects of Pocket Hematoma After Implantation Cardiovascular Implanted Electronic Devices With Pocket Compression Fixation Belt

First Affiliated Hospital Xi'an Jiaotong University0 个研究点目标入组 80 人开始时间: 2020年5月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
主要终点
The incidence and grade of pocket hematoma

研究概览

简要总结

As the number of implanted cardiovascular implanted electronic devices (CIEDs) increases, the incidence of their complications also grows. Pocket hematoma is an important complication of CIED implantation, which has been reported in 2.9-9.5% of CIEDs patients. Pocket hematoma can cause significant pain and interfere with proper wound healing, and it also increased the risk of infection and may prolong length of stay.

Pocket compression is usually applied to compress bleeding vessels and reduce bleeding after implantation. A conventional compression method is to place a sandbag over the pocket, and then using adhesive tape to fix the sandbag. Due to adhesive tape is elastic and the tape may be pulled by patients' activity, sandbag easily migrated from the site. Therefore, nurse must readjust the position of sandbag, or even remove the adhesive tape and perform re-compress. Furthermore, adhesive tape can cause skin erosion. All of which not only result in patients' discomfort and dissatisfaction, but also increase the burden on nurses and wastes resources.

We designed a pocket compression fixation belt. We assumed that using this fixation belt can ensure the compression effect while avoiding sand bag displacement, reducing skin erosion and decrease the workload of care.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Registry of patients undergoing PM, ICD, and CRT-P or CRT-D device implantation in The First Affiliated Hospital of Xi'an Jiaotong University.

排除标准

  • •(1) age<18 years or >80 years, (2) a history of any psychiatric illness, (3) a history of open wounds in the infraclavicular region, (4) coagulation disorder or bleeding diathesis, (5) anticoagulation or antithrombotic treatments could not be interrupted, (6) refusing to participate. This study was approved by the Ethics Committee of the First Affiliated Hospital of Xi'an Jiaotong University (approval number XJTU1AF2020LSK-040).

研究组 & 干预措施

Pocket compression fixation belt

Experimental

Pocket compression belt is used to compress the bleeding vessels and reduce bleeding after implantation.

干预措施: pocket compression fixation belt (Device)

Sand bag compression

Active Comparator

Sand bag compression is used to compress the bleeding vessels and reduce bleeding after implantation.

干预措施: pocket compression fixation belt (Device)

结局指标

主要结局

The incidence and grade of pocket hematoma

时间窗: 48 hours post implantation of ICEDs.

The incidence and grade of pocket hematoma between the control and experimental group were compared

次要结局

  • Operation time and positional adjustment of the sandbag(Accumulate the time used to place and adjust the salt bag within 48 hours for each patient.)

研究者

申办方类型
Other
责任方
Sponsor

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