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

Hospital Clinic of Barcelona

Status: Completed

Conditions: Pocket Hematoma

Treatments: Procedure: hypothermic compression bandage; Procedure: Conventional compression bandage

Study type: Interventional

Funder types: Other

Identifiers

NCT05500768

EYRA trial

Details and patient eligibility

About

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.

Enrollment: 310 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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310 participants in 2 patient groups

hypothermic compression bandage

Experimental group

Treatment:

Procedure: hypothermic compression bandage

Conventional compression bandage

Active Comparator group

Treatment:

Procedure: Conventional compression bandage