Data Collection of Prepectoral Breast Reconstruction With Polyurethane Implantes
NCT ID: NCT06216106
Last Updated: 2024-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
237 participants
OBSERVATIONAL
2020-03-18
2023-10-05
Brief Summary
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Detailed Description
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The 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.
In addition, the investigators would like to define if the postoperative radiation therapy agument the complications rate and the capsular contracture incidence.
The 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
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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patients undergone prepectoral breast reconstruction
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
Prepectoral breast reconstruction with polyurethane implants
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.
Interventions
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Prepectoral breast reconstruction with polyurethane implants
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.
Eligibility Criteria
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Inclusion Criteria
* adequate mastectomy flap in vascularity and thickness
Exclusion Criteria
FEMALE
No
Sponsors
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European Institute of Oncology
OTHER
Responsible Party
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Principal Investigators
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Andrea Vittorio Emanuele Lisa
Role: PRINCIPAL_INVESTIGATOR
Istituto Europeo di Oncologia
Locations
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European Institute of Oncology
Milan, Lombardy, Italy
Countries
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References
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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.
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.
Other Identifiers
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UID 4260
Identifier Type: -
Identifier Source: org_study_id
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