Clinical trial NCT04389398: Prevention of Pocket Hematoma After Implantation Cardiovascular Implanted Electronic Devices
Official title: A Randomized, Controlled Study of Preventing Effects of Pocket Hematoma After Implantation Cardiovascular Implanted Electronic Devices With Pocket Compression Fixation Belt
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematoma Postoperative
Cardiac Resynchronization Therapy Devices
Compression Bandages
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* (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).

Primary outcomes:
measure: The incidence and grade of pocket hematoma
timeFrame: 48 hours post implantation of ICEDs.
Secondary outcomes:
measure: Operation time and positional adjustment of the sandbag
timeFrame: Accumulate the time used to place and adjust the salt bag within 48 hours for each patient.
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Jingwen Hu, Master
role: STUDY_CHAIR
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