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

NCT ID: NCT05500768

Last Updated: 2022-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2022-07-31

Brief Summary

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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

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Conditions

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Pocket Hematoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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hypothermic compression bandage

Group Type EXPERIMENTAL

hypothermic compression bandage

Intervention Type PROCEDURE

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

Conventional compression bandage

Group Type ACTIVE_COMPARATOR

Conventional compression bandage

Intervention Type PROCEDURE

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

Interventions

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hypothermic compression bandage

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

Conventional compression bandage

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

Intervention Type PROCEDURE

Other Intervention Names

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HCB CCB

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Josep Lluis Mont Girbau

Head of Arrythmia Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital ClĂ­nic

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 39162385 (View on PubMed)

Other Identifiers

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EYRA trial

Identifier Type: -

Identifier Source: org_study_id

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