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

Primary Purpose

Pocket Hematoma

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
hypothermic compression bandage
Conventional compression bandage
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pocket Hematoma focused on measuring cardiac devices, surgical wound, oral anticoagulation therapy, oral antiplatelet therapy, compression bandage, hypothermic therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Clínic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

hypothermic compression bandage

Conventional compression bandage

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 10, 2022
Last Updated
August 11, 2022
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT05500768
Brief Title
Efficacy of the hYpothermic Compression Bandage in the Surgical Wound of Cardiac Devices
Acronym
EYRA
Official Title
Efficacy of the hYpothermic Compression Bandage in the Surgical Wound of Cardiac Devices: A RAndomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pocket Hematoma
Keywords
cardiac devices, surgical wound, oral anticoagulation therapy, oral antiplatelet therapy, compression bandage, hypothermic therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hypothermic compression bandage
Arm Type
Experimental
Arm Title
Conventional compression bandage
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
hypothermic compression bandage
Other Intervention Name(s)
HCB
Intervention Description
a compressive bandage is applied for 8 hours to the surgical wound of the cardiac device implants, a frozen prosthesis is added
Intervention Type
Procedure
Intervention Name(s)
Conventional compression bandage
Other Intervention Name(s)
CCB
Intervention Description
a compressive bandage is applied for 8 hours to the surgical wound of the cardiac device implants
Primary Outcome Measure Information:
Title
Appearance of hematoma
Description
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 Outcome Measure Information:
Title
Appearance of severe hematoma
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospital Clínic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

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

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