Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-29 @ 7:36 PM
Study NCT ID:
NCT04290260
Status:
COMPLETED
Last Update Posted:
2020-02-28
First Post:
2019-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of the Bra as Prevention of Sternal Wound Dehiscence in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-27', 'studyFirstSubmitDate': '2019-12-03', 'studyFirstSubmitQcDate': '2020-02-27', 'lastUpdatePostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dehiscence', 'timeFrame': 'Baseline (admission) to 6 months after hospital discharge', 'description': 'Dehiscence in the surgical wound. Criteria defined according to an established scale for the assessment of surgical wounds contemplated in the GacelaCare® computer system used in Germans Trias i Pujol University Hospital. Values may be "Yes" or "No".'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiovascular nursing', 'Bra', 'Dehiscence', 'Sternotomy'], 'conditions': ['Cardiac Surgical Procedures', 'Wound Healing']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to assess the efficacy of bra application as a prevention of dehiscence in women with median sternotomy.', 'detailedDescription': 'Background: it is known that the size and support of the breasts are a specific problem in post-operative women of cardiac surgery by means of medium sternotomy. There is little evidence of the therapeutic action of the bra as a measure to prevent dehiscence of the surgical wound.\n\nAim: To assess the efficacy of bra application as a prevention of dehiscence in women with median sternotomy.\n\nMethods: Randomised clinical trial; post-test control group in women undergoing cardiac surgery by mean sternotomy. Groups: application of post-surgical or non-surgical breast bra. Endpoint: incidence of dehiscence. Other variables: sociodemographic, signs of infection, pain, related to assessment of the wound on admission. Assessment of the surgical wound daily, at discharge, at month, 3 months and 6 months post discharge.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years\n* Cardiac surgery intervention in the Germans Trias i Pujol University Hospital with non-critical preoperative\n* Surgical intervention performed throughout medium sternotomy\n\nExclusion Criteria:\n\n* More than 72 hours admitted in an intensive care unit after surgery\n* Cognitive impairment or severe physical disability\n* Mastectomy\n* External wound occlusion with Opsite® fixative absorbent dressing\n* Emergency surgery'}, 'identificationModule': {'nctId': 'NCT04290260', 'acronym': 'DEHISCENCIA', 'briefTitle': 'Use of the Bra as Prevention of Sternal Wound Dehiscence in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Germans Trias i Pujol Hospital'}, 'officialTitle': 'Randomized Controlled Trial of the Effectiveness of Bra Application in Women as a Device for Prevention of Surgical Wound Dehiscence in the Post-operative Cardiac Surgery', 'orgStudyIdInfo': {'id': 'AC-14-060'}, 'secondaryIdInfos': [{'id': 'PR-1850/14', 'type': 'OTHER_GRANT', 'domain': "Col·legi Oficial d'Infermeres i Infermers de Barcelona"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Use of breast bra', 'description': 'Patients allocated on this group wear a breast bra from admission to hospital discharge.', 'interventionNames': ['Other: Use of breast bra']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Usual care: participants will not wear a breast bra until discharge from the hospital', 'interventionNames': ['Other: Usual care (not use of bra)']}], 'interventions': [{'name': 'Use of breast bra', 'type': 'OTHER', 'description': 'Patients will use a breast from admission to hospital discharge', 'armGroupLabels': ['Use of breast bra']}, {'name': 'Usual care (not use of bra)', 'type': 'OTHER', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}], 'overallOfficials': [{'name': 'Violeta Díaz Herrera, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Germans Trias i Pujol Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Germans Trias i Pujol Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundació Institut Germans Trias i Pujol', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}