Prevention of Pocket Hematoma After Implantation Cardiovascular Implanted Electronic Devices

NCT04389398 | Unknown

• 1 other identifier: XJTU1AF2020LSK-040
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hematoma Postoperative; Cardiac Resynchronization Therapy Devices; Compression Bandages

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Pocket compression fixation belt

EXPERIMENTAL

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

Device: pocket compression fixation belt

Sand bag compression

ACTIVE COMPARATOR

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

Device: pocket compression fixation belt

Interventions

pocket compression fixation belt DEVICE

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

Pocket compression fixation belt; Sand bag compression

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• (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).

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Related Publications (10)

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  PMID: 33675448 DERIVED

Study Officials

• Jingwen Hu, Master

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Jingwen Hu, Master

CONTACT

008618991232872; jingwenhu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 15, 2020
• Study Start: May 25, 2020
• Primary Completion: July 31, 2020
• Study Completion: August 31, 2020
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share