Efficacy of the hYpothermic Compression Bandage in the Surgical Wound of Cardiac Devices: A RAndomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 310
- Locations
- 2
- Primary Endpoint
- Appearance of hematoma
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Appearance of hematoma
Time Frame: 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 Outcomes
- Appearance of severe hematoma(10 days)
Investigators
Josep Lluis Mont Girbau
Head of Arrythmia Unit
Hospital Clinic of Barcelona