Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-02-02 @ 9:00 PM
Study NCT ID:
NCT01789450
Status:
UNKNOWN
Last Update Posted:
2013-04-29
First Post:
2013-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nipple-Areola Complex Sensitivity After the Section of Periareolar Dermis in Breast Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012680', 'term': 'Sensitivity and Specificity'}, {'id': 'D002541', 'term': 'Cerebral Decortication'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013223', 'term': 'Statistics as Topic'}, {'id': 'D055641', 'term': 'Mathematical Concepts'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-04-26', 'studyFirstSubmitDate': '2013-02-04', 'studyFirstSubmitQcDate': '2013-02-08', 'lastUpdatePostDateStruct': {'date': '2013-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Nipple-Areola Complex sensitivity', 'timeFrame': '12 months', 'description': 'To evaluate the sensitivity of the NAC in breast reduction'}], 'primaryOutcomes': [{'measure': 'Nipple-Areola Complex (NAC) Sensitivity', 'timeFrame': '3 weeks', 'description': 'To evaluate the sensitivity of the NAC in breast reduction'}], 'secondaryOutcomes': [{'measure': 'Nipple-Areola Complex (NAC) sensitivity', 'timeFrame': '6 weeks', 'description': 'To evaluate the sensitivity of the NAC in breast reduction'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sensitivity', 'section of periareolar dermis', 'breast reduction'], 'conditions': ['Sensitivity of Nipple-areolar Complex']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the feasibility and sensitivity of nipple-areolar complex (NAC) prospectively due to the section of the dermis after decortication (Schwartzmann's maneuver), in 50 patients undergoing breast reduction surgery.", 'detailedDescription': "Preservation of the dermis after decortication regions of the areola and periareolar is considered relevant by most plastic surgeons.\n\nIn patients whose CAP should be mobilized through large distances in order to correct breast ptosis, or in cases of dense breasts where noted little slip of skin over the breast parenchyma, the periareolar dermis causes limitation on the mobility of the NAC.\n\nIn clinical practice, there is a greater mobilization of NAC when making a careful section of the dermis after decortication. In contrast, the appearance of partial necrosis in these cases has become a rarity, as no case of total necrosis was observed.\n\nGiven the technical benefit observed due to greater mobilization, there is no report in the literature about how behaves the sensitivity of the NAC in these cases.\n\nTo evaluate the sensitivity of the NAC will be used Semmes-Weisnstein's monofilament. Each point will be obtained five measurements. The largest will be scorned and the lowest value. The final value of each point corresponds to an arithmetic mean of the three remaining values."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who willingly seek the service requesting breast reduction or mastopexy;\n* Patients who after consultation with the surgeon who led the research presents realistic expectation, being safe with the possible outcome of the surgery;\n* Patients who undertake to comply with the protocol previously presented and discussed with them;\n\nExclusion Criteria:\n\n* Patients with prior breast surgery;\n* Patients with body mass index (BMI) greater than 34.9;\n* Patients with severe anemia;\n* Patients with neurological disease;\n* Patients with impairment cardiovascular;\n* Metabolic diseases - diabetes;\n* Patients with autoimmune disease;\n* Menopausal patients\n* Patients with collagen disease;\n* Patients with psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT01789450', 'briefTitle': 'Nipple-Areola Complex Sensitivity After the Section of Periareolar Dermis in Breast Reduction', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Pernambuco'}, 'orgStudyIdInfo': {'id': 'UFPE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Section of Periareolar Dermis', 'description': 'Section of Periareolar Dermis', 'interventionNames': ['Procedure: Section of Periareolar Dermis in Breast Reduction.']}], 'interventions': [{'name': 'Section of Periareolar Dermis in Breast Reduction.', 'type': 'PROCEDURE', 'otherNames': ['Sensitivity', 'Nipple-Areolar Complex (NAC)', 'Breast Reduction', "Schwartzmann's Maneuver", 'Decortication'], 'armGroupLabels': ['Section of Periareolar Dermis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50670-607', 'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'contacts': [{'name': 'Jairo Z Sá, surgeon', 'role': 'CONTACT', 'email': 'jairozacche@gmail.com', 'phone': '81 34675717', 'phoneExt': '+55'}, {'name': 'Jairo Z Sá, surgeon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital das clínicas da UFPE', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}], 'centralContacts': [{'name': 'Jairo Z Sá, surgeon', 'role': 'CONTACT', 'email': 'jairozacche@gmail.com', 'phone': '81 34675717', 'phoneExt': '+55'}], 'overallOfficials': [{'name': 'Jairo Z Sá, surgeon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital das Clínicas da Universidade Federal de Pernambuco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal de Pernambuco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Jairo Zacchê de Sá', 'investigatorFullName': 'Jairo Zacchê de Sá', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}