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

Not Applicable

Completed

• Conditions: Pocket Hematoma
• Interventions: Procedure: Conventional compression bandage; Procedure: hypothermic compression bandage

• Registration Number: NCT05500768
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Primary Completion: 2019-05-31
• Study Completion: 2022-07-31
• Status Verified: 2022-08
• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-11
• Last Update Submitted: 2022-08-11
• Study First Posted: 2022-08-15
• Last Update Posted: 2022-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional compression bandage	Conventional compression bandage	-
hypothermic compression bandage	hypothermic compression bandage	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Clínic; 🇪🇸 Barcelona, Spain