Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-25 @ 3:13 PM
Study NCT ID:
NCT05500768
Status:
COMPLETED
Last Update Posted:
2022-08-15
First Post:
2022-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of the hYpothermic Compression Bandage in the Surgical Wound of Cardiac Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006581', 'term': 'Hexachlorobenzene'}], 'ancestors': [{'id': 'D002722', 'term': 'Chlorobenzenes'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006843', 'term': 'Hydrocarbons, Chlorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-11', 'studyFirstSubmitDate': '2022-08-10', 'studyFirstSubmitQcDate': '2022-08-11', 'lastUpdatePostDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appearance of hematoma', 'timeFrame': '10 days', 'description': "Classification of pocket hematoma according to DeSensi et al.:\n\nGrade I: ecchymosis, defined as minor bleeding in the cardiac device pocket, no swelling or pain (watch and wait).\n\nGrade 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"}], 'secondaryOutcomes': [{'measure': 'Appearance of severe hematoma', 'timeFrame': '10 days', 'description': "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"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac devices', 'surgical wound', 'oral anticoagulation therapy', 'oral antiplatelet therapy', 'compression bandage', 'hypothermic therapy'], 'conditions': ['Pocket Hematoma']}, 'referencesModule': {'references': [{'pmid': '39162385', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* insertion of drainage in the wound,\n* non-compliance with the pre-surgical antithrombotic protocol\n* INR in a high therapeutic range (\\>3.5)\n* Do not follow-up in the same hospital\n* Coagulation and hemostasis disorders\n* Replacement of devices due to alterations in the operation unrelated to the battery.'}, 'identificationModule': {'nctId': 'NCT05500768', 'acronym': 'EYRA', 'briefTitle': 'Efficacy of the hYpothermic Compression Bandage in the Surgical Wound of Cardiac Devices', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Efficacy of the hYpothermic Compression Bandage in the Surgical Wound of Cardiac Devices: A RAndomized Controlled Trial', 'orgStudyIdInfo': {'id': 'EYRA trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hypothermic compression bandage', 'interventionNames': ['Procedure: hypothermic compression bandage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional compression bandage', 'interventionNames': ['Procedure: Conventional compression bandage']}], 'interventions': [{'name': 'hypothermic compression bandage', 'type': 'PROCEDURE', 'otherNames': ['HCB'], 'description': 'a compressive bandage is applied for 8 hours to the surgical wound of the cardiac device implants, a frozen prosthesis is added', 'armGroupLabels': ['hypothermic compression bandage']}, {'name': 'Conventional compression bandage', 'type': 'PROCEDURE', 'otherNames': ['CCB'], 'description': 'a compressive bandage is applied for 8 hours to the surgical wound of the cardiac device implants', 'armGroupLabels': ['Conventional compression bandage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Arrythmia Unit', 'investigatorFullName': 'Josep Lluis Mont Girbau', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}