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

Hospital Clinic of Barcelona310 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

310

Conditions

Pocket Hematoma

Interventions

hypothermic compression bandagePROCEDURE

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

Conventional compression bandagePROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Clínic

Barcelona, Spain

Outcomes

Primary Outcomes

Appearance of hematoma

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

Time frame: 10 days

Secondary Outcomes

Appearance of severe hematoma

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

Time frame: 10 days

Data from ClinicalTrials.gov

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