Prevention of Pocket Hematoma After Implantation Cardiovascular Implanted Electronic Devices

May 12, 2020 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pocket compression fixation belt
Pocket compression belt is used to compress the bleeding vessels and reduce bleeding after implantation.
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.
Active Comparator: Sand bag compression
Sand bag compression is used to compress the bleeding vessels and reduce bleeding after implantation.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence and grade of pocket hematoma
Time Frame: 48 hours post implantation of ICEDs.
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
Time Frame: 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.
Accumulate the time used to place and adjust the salt bag within 48 hours for each patient.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Study Chair: Jingwen Hu, Master, First Affiliated Hospital Xi'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 25, 2020

Primary Completion (Anticipated)

July 31, 2020

Study Completion (Anticipated)

August 31, 2020

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 15, 2020

Study Record Updates

Last Update Posted (Actual)

May 15, 2020

Last Update Submitted That Met QC Criteria

May 12, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2020LSK-040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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