Prevention of Pocket Hematoma After Implantation Cardiovascular Implanted Electronic Devices

Study Overview
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Brief Summary
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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.

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

Conditions
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Hematoma Postoperative, Cardiac Resynchronization Therapy Devices, Compression Bandages

Intervention / Treatment
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* Device: pocket compression fixation belt


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pocket compression fixation belt<br>Pocket compression belt is used to compress the bleeding vessels and reduce bleeding after implantation. | Device: pocket compression fixation belt<br>* Pocket compression fixation belt to is used to compress the postoperative wounds of CIEDS patients, and its effect of preventing hematoma is evaluated.<br>|
| Active Comparator: Sand bag compression<br>Sand bag compression is used to compress the bleeding vessels and reduce bleeding after implantation. | Device: pocket compression fixation belt<br>* Pocket compression fixation belt to is used to compress the postoperative wounds of CIEDS patients, and its effect of preventing hematoma is evaluated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and grade of pocket hematoma | The incidence and grade of pocket hematoma between the control and experimental group were compared | 48 hours post implantation of ICEDs. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time and positional adjustment of the sandbag | Operation time refer to the consuming minutes that perform compression procedure for each patient, including the total time to fix the salt bag and remove the salt bag twice during intermittent compression. | Accumulate the time used to place and adjust the salt bag within 48 hours for each patient. |