Prevention of Pocket Hematoma After Implantation Cardiovascular Implanted Electronic Devices

Not Applicable

• Conditions: Compression Bandages; Cardiac Resynchronization Therapy Devices; Hematoma Postoperative
• Interventions: Device: pocket compression fixation belt

• Registration Number: NCT04389398
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-12
• Last Update Submitted: 2020-05-12
• Study First Posted: 2020-05-15
• Last Update Posted: 2020-05-15
• Study Start: 2020-05-25
• Primary Completion: 2020-07-31
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pocket compression fixation belt	pocket compression fixation belt	Pocket compression belt is used to compress the bleeding vessels and reduce bleeding after implantation.
Sand bag compression	pocket compression fixation belt	Sand bag compression is used to compress the bleeding vessels and reduce bleeding after implantation.

Primary Outcome Measures

Name	Time	Method
The incidence and grade of pocket hematoma	48 hours post implantation of ICEDs.	The incidence and grade of pocket hematoma between the control and experimental group were compared

Secondary Outcome Measures

Name	Time	Method
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.	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.