Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT05424666
Status:
UNKNOWN
Last Update Posted:
2022-06-21
First Post:
2021-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Lipofilling After Oncoplastic Breast Surgeries : Evaluation of Outcomes and Patient Satisfaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-19', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-15', 'studyFirstSubmitDate': '2021-12-27', 'studyFirstSubmitQcDate': '2022-06-15', 'lastUpdatePostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cosmetic apperance', 'timeFrame': '1 week', 'description': 'Volumetric evaluation of breast after surgery and symmetry to the other breast'}], 'secondaryOutcomes': [{'measure': 'Complications during the treatment and follow up', 'timeFrame': '1 month', 'description': 'Complications during the treatment Follow-up period will be registered and compared between the intervention and control groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer, Breast']}, 'descriptionModule': {'briefSummary': 'The Role of Lipofilling After Oncoplastic Breast surgeries : Evaluation of Outcomes and Patient Satisfaction', 'detailedDescription': 'Lipofilling is the process of relocating autologous fat to change the shape, volume, consistency and profile of tissues. For over a century, surgeons have used autologous fat to enlarge and reshape the breasts.\n\nAutologous fat grafting has gained popularity in recent years, although concerns exist regarding the safety and efficacy of this practice in breast surgery . Autologous fat grafting represents an important tool for the management of secondary contour deformities of reconstructed breasts; fat grafting is a simple, safe, and effective treatment option, with low morbidity. it is a straightforward and quick reconstructive technique that does not generally interfere with adjuvant therapies .patient surveys have demonstrated that irradiation has a significant and negative effect on patient satisfaction . Fat grafting seems to reduce radiation induced complications .improve cosmetic results, and reduce postoperative discomfort and pain. The aim of this study is to measure patient satisfaction with their breasts, as well as quality of life.\n\nWith the advent of liposuction in the 1980s, large amounts of unwanted fat could be removed from different body areas using small access incisions and a suction cannula. In this setting, fat grafting was re-introduced in the early 80s, pioneered by the American Mel Bircoll, who first described a series of fat transplantation for breast augmentation and reconstruction'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nFemale gender.\n\nAge of 18 years and older.\n\nHistory or in candidate for a mastectomy in the near future.\n\nPatients undergoing prophylactic mastectomy.\n\nPatients' choice to undergo a breast reconstruction.\n\nWanting to participate in this study.\n\nPatient is able to wear the BRAVA (BRA like VAcuum-based external tissue expander) device.\n\nExclusion Criteria:\n\nActive smoker or a history of smoking 4 weeks prior to surgery.\n\nCurrent substance abuse.\n\nHistory of lidocaine allergy.\n\nFour weeks or less after chemotherapy.\n\nHistory of radiation therapy in the breast region.\n\nOncological treatment includes radiotherapy after mastectomy.\n\nKidney disease.\n\nSteroid dependent (daily or weekly).\n\nImmune-suppressed or immune-compromised disease.\n\nUncontrolled diabetes.\n\nbody mass index of \\>30.\n\nLarge breast size (ie, larger than cup C), unless the patient prefers reduction of the contralateral side towards cup C.\n\nExtracapsular silicone leaking from the encapsulated implant from a previous breast reconstruction."}, 'identificationModule': {'nctId': 'NCT05424666', 'briefTitle': 'The Role of Lipofilling After Oncoplastic Breast Surgeries : Evaluation of Outcomes and Patient Satisfaction', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Role of Lipofilling After Oncoplastic Breast Surgeries : Evaluation of Outcomes and Patient Satisfaction', 'orgStudyIdInfo': {'id': 'Oncoplastic breast surgeries'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient going Oncoplastic Breast surgeries', 'description': 'Lipofilling After Oncoplastic Breast surgeries : Evaluation of Outcomes and Patient Satisfaction', 'interventionNames': ['Procedure: Harvesting method and Fat graft preparation method']}], 'interventions': [{'name': 'Harvesting method and Fat graft preparation method', 'type': 'PROCEDURE', 'description': 'The procedure begins by identifying the areas where the fat will be collected Then the sample is collected by micro-incision using a fine suction cannula or during conventional liposuction. The fat cells are taken from an area of the body where there is a reserve (generally, in the abdomen, hips, knees, inner thighs, buttock) The collected fat cells are then subjected to a sterile centrifugation for a few minutes so as to separate the cells that will be injected (intact fat cells) from the elements that must not be injected (fat cells destroyed by the sample, non-fat cells such as than blood cells).\n\nInjection of fat cells into the breasts The reinjection of fat (lipofilling) is performed using micro-cannulas allowing incisions of the order of 1-2 mm in different angles and in multiple directions so as to increase the contact area between the grafted cells and the recipient tissues allowing a "good grip" of the injection.', 'armGroupLabels': ['Patient going Oncoplastic Breast surgeries']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mina Rashad', 'role': 'CONTACT', 'email': 'minarashad36@gmail.com', 'phone': '+201016633429'}, {'name': 'Ahmed Kema, Study director', 'role': 'CONTACT'}], 'facility': 'Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '3 years', 'ipdSharing': 'YES', 'description': 'Age / sex / clincal diagnosis', 'accessCriteria': 'Assiut university'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assiut lecturer', 'investigatorFullName': 'mina rashad helmy besada', 'investigatorAffiliation': 'Assiut University'}}}}