Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-27 @ 4:36 AM
Study NCT ID:
NCT02569866
Status:
COMPLETED
Last Update Posted:
2018-04-20
First Post:
2015-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotics After Breast Reduction:Clinical Trial With Randomization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D014946', 'term': 'Wound Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002506', 'term': 'Cephalexin'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-18', 'studyFirstSubmitDate': '2015-10-04', 'studyFirstSubmitQcDate': '2015-10-05', 'lastUpdatePostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical site infection in the postoperative of reduction mammaplasty.', 'timeFrame': '30 days postoperatively', 'description': 'After surgery, the patients will be followed for 30 days and surgical site infection rates will be observed in both groups, according to the CDC criteria.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['plastic surgery', 'mammaplasty', 'wound infection', 'prophylaxis'], 'conditions': ['Surgical Site Infection']}, 'referencesModule': {'references': [{'pmid': '20585232', 'type': 'BACKGROUND', 'citation': 'Veiga-Filho J, Veiga DF, Sabino-Neto M, Amorim MC, Novo NF, Ferreira LM. The role of antibiotics in reduction mammaplasty. Ann Plast Surg. 2010 Aug;65(2):144-6. doi: 10.1097/SAP.0b013e3181c47d88.'}, {'pmid': '27899130', 'type': 'DERIVED', 'citation': 'Garcia ES, Veiga DF, Veiga-Filho J, Cabral IV, Pinto NL, Novo NF, Sabino Neto M, Ferreira LM. Antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial. Trials. 2016 Nov 30;17(1):567. doi: 10.1186/s13063-016-1700-y.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to determine the role of antibiotics reduction mammaplasty influence surgical site infections rates.', 'detailedDescription': 'Prevention of SSI is important due to its morbidity, longer hospital stays and higher costs. In many surgical procedures where the risk of infection is relatively low and the postoperative infection can be treated properly, the role of antibiotics is not clear.\n\nDespite the lack of evidence from prospective randomized controlled trials of evaluation, the use of antibiotics in plastic surgery is widespread in order to offer the highest safety standards patients.\n\nThe breast reduction is defined as "clean surgery" with a lower infection rate to 3.4%. Thus, the antibiotic is not recommended. However, studies have shown a real rate of infection associated with procedures ranging from 4-36%.\n\nThus, this trial was designed to verify the role of antibiotics in reduction mammaplasty.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast hypertrophy\n* Body mass index between 19 to 30 kg/m2\n\nExclusion Criteria:\n\n* Patients undergoing a surgical procedure in the breast\n* Diagnosis of breast pathology\n* Smoking\n* Childbirth or lactation less than a year\n* Uncontrolled comorbidities\n* Use of immunosuppressive drugs\n* Misuse of capsules supplied\n* Absence during the weekly follow-up'}, 'identificationModule': {'nctId': 'NCT02569866', 'briefTitle': 'Antibiotics After Breast Reduction:Clinical Trial With Randomization', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Antibiotics After Breast Reduction:Clinical Trial With Randomization', 'orgStudyIdInfo': {'id': 'ESG180402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Antibiotics Group', 'description': 'Capsules containing cephalexin/500mg will be administrated to the subjects, 4 times daily, for seven days during the postoperative period of reduction mammaplasty.', 'interventionNames': ['Drug: Cephalexin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Capsules containing placebo/500mg will be administrated to the subjects, 4 times daily, for seven days during the postoperative period of reduction mammaplasty.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cephalexin', 'type': 'DRUG', 'description': 'Capsules containing cephalexin/500mg', 'armGroupLabels': ['Antibiotics Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsules containing placebo/500mg', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37553079', 'city': 'Pouso Alegre', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital das Clínicas Samuel Libanio', 'geoPoint': {'lat': -22.23, 'lon': -45.93639}}], 'overallOfficials': [{'name': 'Lydia M Ferreira, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidade do Vale do Sapucai', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Edgard da Silva Garcia, Professor, Universidade do Vale do Sapucaí', 'investigatorFullName': 'Edgard da Silva Garcia', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}