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

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Completed

CT.gov ID

NCT05500768

Collaborator

(none)

310

Enrollment

Location

Arms

Actual Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pocket Hematoma	Procedure: hypothermic compression bandage Procedure: Conventional compression bandage	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

310 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 1, 2018

Actual Primary Completion Date :

May 31, 2019

Actual Study Completion Date :

Jul 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Appearance of hematoma [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 Outcome Measures

Appearance of severe hematoma [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.