Pocket Hematoma
Conditions
Keywords
cardiac devices, surgical wound, oral anticoagulation therapy, oral antiplatelet therapy, compression bandage, hypothermic therapy
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.
Interventions
PROCEDUREhypothermic compression bandage
a compressive bandage is applied for 8 hours to the surgical wound of the cardiac device implants, a frozen prosthesis is added
PROCEDUREConventional compression bandage
a compressive bandage is applied for 8 hours to the surgical wound of the cardiac device implants
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Outcome results
None listed