Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-29 @ 4:34 PM
Study NCT ID:
NCT06216106
Status:
COMPLETED
Last Update Posted:
2024-01-22
First Post:
2023-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Data Collection of Prepectoral Breast Reconstruction With Polyurethane Implantes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 237}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-11', 'studyFirstSubmitDate': '2023-12-21', 'studyFirstSubmitQcDate': '2024-01-11', 'lastUpdatePostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reconstruction failure', 'timeFrame': '12 months', 'description': 'loss of implant or switch to autologus recosntruction'}, {'measure': 'major complications', 'timeFrame': '12months', 'description': 'evaluation of hematoma, infection, flap necrosis, wound dehiscence rate'}, {'measure': 'minor complications', 'timeFrame': '12 months', 'description': 'evaluation of seroma, rippling, casular contracture, asymmetry rate'}, {'measure': 'risk factor', 'timeFrame': '12 months', 'description': 'evaluation of the risk factors correlated to recostruction failure'}], 'secondaryOutcomes': [{'measure': 'postoperative radiation therapy on patients underwent prepectoral breast reconstruction with polyurethane implantes', 'timeFrame': '12 months', 'description': 'evaluation if the post operative radiation therapy is correlated with an increase of reconstruction failure and capsular contracture'}, {'measure': 'patients previously irradiated (QUART) and underwent prepectoral breast reconstruction with polyurethane implantes', 'timeFrame': '12 months', 'description': 'analysis of clinical characteristics of pre irradiatred patients submitted to prepectoral breast recosntruction with polyurethane implantes'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PPBR', 'POLYURETHANE', 'IBR', 'RADIOTHERAPY', 'BREAST IMPLANTS'], 'conditions': ['Prepectoral Breast Reconstruction', 'Breast Reconstruction', 'Radiation Therapy Complication']}, 'referencesModule': {'references': [{'pmid': '33627298', 'type': 'BACKGROUND', 'citation': 'Salgarello M, Pagliara D, Barone Adesi L, Visconti G, Wild JB, Matey P. Direct to Implant Breast Reconstruction With Prepectoral Micropolyurethane Foam-Coated Implant: Analysis of Patient Satisfaction. Clin Breast Cancer. 2021 Aug;21(4):e454-e461. doi: 10.1016/j.clbc.2021.01.015. Epub 2021 Jan 23.'}, {'pmid': '30691930', 'type': 'BACKGROUND', 'citation': 'de Vita R, Buccheri EM, Villanucci A, Pozzi M. Breast Reconstruction Actualized in Nipple-sparing Mastectomy and Direct-to-implant, Prepectoral Polyurethane Positioning: Early Experience and Preliminary Results. Clin Breast Cancer. 2019 Apr;19(2):e358-e363. doi: 10.1016/j.clbc.2018.12.015. Epub 2018 Dec 27.'}]}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to learn about correct surgical indications and long-term complications in patient with immediate prepectoral breast reconstruction with polyurethane implants. The main question it aims to answer are: what are the correct indications for this type of reconstruction? what is the complications rates? are the complications affected by pre and post operative radiotherapy? It's a retrospective study of all the patients that received prepectoral breast reconstruction with polyurethane implants without any exclusion factors. Researchers will compare the non-irradiated group with the patients with pre and post radiation therapy.", 'detailedDescription': 'The study is a data collection of 250 patients for a total of 317 breasts underwent prepectoral breast recosntruction with polyurethane implantes. It is a retrospective study of a single center. The investigators gave indication to that type of reconstruction only to patients with good thickness (\\> 0.5 cm) and vascularity of skin flap after mastectomy.\n\nThe investigators used not selective criteria regarding risk factors so to better evaluate wich of them has a negative trend on the success of the reconstruction and on the major and minor complications. In that way the investigators tried to definde clarly the correct indications for this type of reconstruction.\n\nIn addition, the investigators would like to define if the postoperative radiation therapy agument the complications rate and the capsular contracture incidence.\n\nThe investigators decide to perform prepectoral breast reconstruction also in 20 patientes underwent previous radiotherapy dependig on the grade of cutaneus radiodistrophy, so to propose our less invasive approach to these patients normally candidates to autologus breast reconstruction'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patientes undergone immediate prepectoral breast reconstruction with polyurethane implantes', 'genderDescription': 'we included only famale patients underwent mastectomy and immediate breast reconstruction in the prepectoral plane with polyurethane implantes', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients underwent prepectoral breast recosntruction with polyurethane implants after skin or nipple sparing masectomy\n* adequate mastectomy flap in vascularity and thickness\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT06216106', 'acronym': 'IBR-PPBR', 'briefTitle': 'Data Collection of Prepectoral Breast Reconstruction With Polyurethane Implantes', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'Prepectoral Breast Reconstruction With Polyurethane Implantes and Radiotherapy: a Single Center Retrospective Study Evaluating Risk and Complications', 'orgStudyIdInfo': {'id': 'UID 4260'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients undergone prepectoral breast reconstruction', 'description': 'As the retrospective nature of this study, we have no exlusion criterias. We included all the patients with prepectoral breast reconstruction with polyurethane covered implants. We also included patients underwent postoperative radiation therapy (50 patients) and 20 patients with history of previous radiotherapy', 'interventionNames': ['Procedure: Prepectoral breast reconstruction with polyurethane implants']}], 'interventions': [{'name': 'Prepectoral breast reconstruction with polyurethane implants', 'type': 'PROCEDURE', 'description': 'Breast reconstruction in the prepectoral plane without elevate the pectoralis major muscle. We choose this type of reconstruction only in patients with mastectomy flap thickness of plus then 0.5 cm. We usally use silicone implants covered by an external layer of polyurethane so not to put directly in contact the silicone with the subcutaneus tissue.', 'armGroupLabels': ['patients undergone prepectoral breast reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20141', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Andrea Vittorio Emanuele Lisa', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Europeo di Oncologia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}