Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-02 @ 8:23 AM
Study NCT ID:
NCT01553604
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2012-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dressing Wear Time After Breast Augmentation With Prosthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-03', 'studyFirstSubmitDate': '2012-03-12', 'studyFirstSubmitQcDate': '2012-03-13', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'skin colonization', 'timeFrame': '6 days postoperatively', 'description': 'skin colonization will be measured through semi-quantitative cultures of samples collected pre-dressing and on 6th postoperative day.'}], 'secondaryOutcomes': [{'measure': 'surgical site infection', 'timeFrame': '30 days postoperatively', 'description': 'Surgical site infection will be assessed weekly, for 30 days. CDC´s criteria and definitions will be used.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast prosthesis implantation', 'bandages', 'skin colonization', 'surgical site infection', 'augmentation mammaplasty', 'dressing wear time'], 'conditions': ['Surgical Site Infection']}, 'referencesModule': {'references': [{'pmid': '25623237', 'type': 'BACKGROUND', 'citation': 'Mendes Dde A, Veiga DF, Veiga-Filho J, Fonseca FE, de Paiva LF, Novo NF, Loyola AB, Ferreira LM. Application time for postoperative wound dressing following breast augmentation with implants: study protocol for a randomized controlled trial. Trials. 2015 Jan 27;16:19. doi: 10.1186/s13063-014-0529-5.'}, {'pmid': '29475792', 'type': 'RESULT', 'citation': 'Mendes DA, Veiga DF, Veiga-Filho J, Loyola ABAT, Paiva LF, Novo NF, Sabino-Neto M, Ferreira LM. Influence of dressing application time after breast augmentation on cutaneous colonization: A randomized clinical trial. J Plast Reconstr Aesthet Surg. 2018 Jun;71(6):906-912. doi: 10.1016/j.bjps.2018.01.021. Epub 2018 Feb 21.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to determine whether the duration of dressing wear following augmentation mammaplasty influence skin colonization and eventually surgical site infections rates.', 'detailedDescription': 'Augmentation mammaplasty is currently one of the most performed plastic surgery procedures. It is a clean operation, and surgical site infection (SSI) rates are low. However, a SSI, since a minor one, leads to the failure of the procedure. Thus, minimizing SSI risks is imperative.\n\nThe Centers for Disease Control and Prevention (CDC) provides recommendations concerning prevention of SSI.No recommendation is offered for some practices, either because there is a lack of consensus regarding their efficacy or because of the available scientific evidence is insufficient to support their adoption.\n\nCDC´s "Guideline for Prevention of Surgical Site Infection" recommends protecting with a sterile dressing for 24 to 48 hours an incision that has been closed primarily. There is no recommendation to cover the incision beyond 48 hours. One major risk factor for SSI is the presence of bacteria at surgical site.Thus, this trial was designed to verify the influence of dressing wear time on skin colonization.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* candidate to breast prosthesis implantation\n* body mass index under 30Kg/m2\n\nExclusion Criteria:\n\n* pregnancy, delivery or breast feeding during the last 12 months\n* body mass index over 30Kg/m2\n* breast cancer history\n* previous breast surgery\n* hard smoking'}, 'identificationModule': {'nctId': 'NCT01553604', 'briefTitle': 'Dressing Wear Time After Breast Augmentation With Prosthesis', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Influence of Dressing Wear Time on Skin Colonization After Breast Augmentation With Prosthesis: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Micro02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Postoperative day 6', 'description': 'Dressing is removed on the sixth postoperative day', 'interventionNames': ['Procedure: augmentation mammaplasty']}, {'type': 'EXPERIMENTAL', 'label': 'Postoperative day 1', 'description': 'Dressing is removed on the first postoperative day', 'interventionNames': ['Procedure: augmentation mammaplasty']}], 'interventions': [{'name': 'augmentation mammaplasty', 'type': 'PROCEDURE', 'description': 'Dressing is removed on the first postoperative day', 'armGroupLabels': ['Postoperative day 1']}, {'name': 'augmentation mammaplasty', 'type': 'PROCEDURE', 'description': 'Dressing is removed on the 6th postoperative day', 'armGroupLabels': ['Postoperative day 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37550000', 'city': 'Pouso Alegre', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital das Clínicas Samuel Libanio', 'geoPoint': {'lat': -22.23, 'lon': -45.93639}}], 'overallOfficials': [{'name': 'Daniela F Veiga, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidade Federal de São Paulo'}, {'name': 'Joel Veiga-Filho, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade do Vale do Sapucaí'}, {'name': 'Lydia M Ferreira, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidade Federal de São Paulo'}, {'name': 'Denise A Mendes, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal de São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daniela Francescato Veiga', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Daniela Francescato Veiga', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}