Efficacy of the hYpothermic Compression Bandage in the Surgical Wound of Cardiac Devices (EYRA)

August 11, 2022 updated by: Josep Lluis Mont Girbau, Hospital Clinic of Barcelona

Efficacy of the hYpothermic Compression Bandage in the Surgical Wound of Cardiac Devices: A RAndomized Controlled Trial

The aim of this study is to evaluate the efficacy of hypothermic compression bandaging versus conventional compression bandaging, for the prevention of surgical wound hematoma of cardiac implementable electronic devices in patients undergoing chronic oral anticoagulant therapy and/or oral antiplatelet therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

310

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.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients under oral anticoagulation and/or antiplatelet treatment who were going to undergo implantation of an implanted device cardiac stimulation or generator replacement due to battery depletion

Exclusion Criteria:

  • insertion of drainage in the wound,
  • non-compliance with the pre-surgical antithrombotic protocol
  • INR in a high therapeutic range (>3.5)
  • Do not follow-up in the same hospital
  • Coagulation and hemostasis disorders
  • Replacement of devices due to alterations in the operation unrelated to the battery.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hypothermic compression bandage
Procedure: hypothermic compression bandage
a compressive bandage is applied for 8 hours to the surgical wound of the cardiac device implants, a frozen prosthesis is added
Other Names:
  • HCB
Active Comparator: Conventional compression bandage
Procedure: Conventional compression bandage
a compressive bandage is applied for 8 hours to the surgical wound of the cardiac device implants
Other Names:
  • CCB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appearance of hematoma
Time Frame: 10 days

Classification of pocket hematoma according to DeSensi et al.:

Grade I: ecchymosis, defined as minor bleeding in the cardiac device pocket, no swelling or pain (watch and wait).

Grade II: medium hematoma described as a palpable, bulging mass of <2cm over the implanted generator. Moderate bleeding in the pocket of the MCP or ICD, causing functional impairment or pain in the area of the heart device Grade III: severe hematoma Determined as a palpable, bulging mass >2cm. Evacuation is required if it causes tension in the skin with poor tissue perfusion, which is increasing and generates severe pain. Prolongs the patient's hospitalization or readmission for more than 24 hours. Requires immediate discontinuation of OACs or oral antiplatelets
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appearance of severe hematoma
Time Frame: 10 days
severe hematoma Determined as a palpable, bulging mass >2cm. Evacuation is required if it causes tension in the skin with poor tissue perfusion, which is increasing and generates severe pain. Prolongs the patient's hospitalization or readmission for more than 24 hours. Requires immediate discontinuation of OACs or oral antiplatelets
10 days

Collaborators and Investigators

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

Sponsor

Hospital Clinic of Barcelona

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 (Actual)

May 1, 2018

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

July 31, 2022

Study Registration Dates

First Submitted

August 10, 2022

First Submitted That Met QC Criteria

August 11, 2022

First Posted (Actual)

August 15, 2022

Study Record Updates

Last Update Posted (Actual)

August 15, 2022

Last Update Submitted That Met QC Criteria

August 11, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYRA trial

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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