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

Study Overview
=================
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.

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

Conditions
-----------------
Pocket Hematoma

Intervention / Treatment
-----------------
* Procedure: hypothermic compression bandage
* Procedure: Conventional compression bandage


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypothermic compression bandage<br> | Procedure: hypothermic compression bandage<br>* a compressive bandage is applied for 8 hours to the surgical wound of the cardiac device implants, a frozen prosthesis is added<br>* Other names: HCB;|
| Active Comparator: Conventional compression bandage<br> | Procedure: Conventional compression bandage<br>* a compressive bandage is applied for 8 hours to the surgical wound of the cardiac device implants<br>* Other names: CCB;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac devices, surgical wound, oral anticoagulation therapy, oral antiplatelet therapy, compression bandage, hypothermic therapy