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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypothermic compression bandage | Experimental |
| |
| Conventional compression bandage | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39162385 | Derived | 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. |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D006581 | Hexachlorobenzene |
| ID | Term |
|---|---|
| D002722 | Chlorobenzenes |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Conventional compression bandage | Procedure | a compressive bandage is applied for 8 hours to the surgical wound of the cardiac device implants |
|
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D006843 | Hydrocarbons, Chlorinated |
| D006846 | Hydrocarbons, Halogenated |