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

NCT05500768 | Completed

• 1 other identifier: EYRA trial
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

Pocket Hematoma

Keywords

cardiac devices; surgical wound; oral anticoagulation therapy; oral antiplatelet therapy; compression bandage; hypothermic therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Appearance of severe hematoma

  10 days

Study Arms (2)

hypothermic compression bandage

EXPERIMENTAL

Procedure: hypothermic compression bandage

Conventional compression bandage

ACTIVE COMPARATOR

Procedure: Conventional compression bandage

Interventions

hypothermic compression bandage PROCEDURE

a compressive bandage is applied for 8 hours to the surgical wound of the cardiac device implants, a frozen prosthesis is added

Also known as: HCB

hypothermic compression bandage

Conventional compression bandage PROCEDURE

a compressive bandage is applied for 8 hours to the surgical wound of the cardiac device implants

Also known as: CCB

Conventional compression bandage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic

Barcelona, 08036, Spain

Location

Related Publications (1)

• Cano Valls A, Niebla M, Diago C, Domingo R, Tolosana JM, Perez S. Efficacy of Hypothermic Compression Bandages in Cardiac Device Surgical Wounds: A Randomized Controlled Trial. Adv Skin Wound Care. 2024 Sep 1;37(9):1-7. doi: 10.1097/ASW.0000000000000201.

  PMID: 39162385 DERIVED

MeSH Terms

Conditions

Surgical Wound

Interventions

Hexachlorobenzene

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chlorobenzenes; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Arrythmia Unit

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 15, 2022
• Study Start: May 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: July 31, 2022
• Last Updated: August 15, 2022

Record last verified: 2022-08

Locations

ES (1)