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Completed

NCT Number: NCT05500768

Efficacy of the hYpothermic Compression Bandage in the Surgical Wound of Cardiac Devices

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.

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Key information

Conditions

Pocket Hematoma Surgical Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínic

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hypothermic compression bandage

Procedure

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

Conventional compression bandage

Procedure

a compressive bandage is applied for 8 hours to the surgical wound of the cardiac device implants

Other names: CCB

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Acronym: EYRA

Important dates

Study start
2018
Primary completion
2019
Study completion
2022
First posted
Aug 15, 2022
Registry last updated
Aug 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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