Prevention of Pocket Hematoma After Implantation Cardiovascular Implanted Electronic Devices

Hematoma Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04389398
• Other study ID #: XJTU1AF2020LSK-040
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 25, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: May 2020
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Jingwen Hu, Master
• Phone: 008618991232872
• Email: jingwenhu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy Devices
• Compression Bandages
• Hematoma
• Hematoma Postoperative

Intervention

Device:
• pocket compression fixation belt
Pocket compression fixation belt to is used to compress the postoperative wounds of CIEDS patients, and its effect of preventing hematoma is evaluated.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

References & Publications (9)

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Palmisano P, Accogli M, Zaccaria M, Luzzi G, Nacci F, Anaclerio M, Favale S. Rate, causes, and impact on patient outcome of implantable device complications requiring surgical revision: large population survey from two centres in Italy. Europace. 2013 Apr;15(4):531-40. doi: 10.1093/europace/eus337. Epub 2013 Feb 13. — View Citation

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.