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The study plans to compare conventional submuscular reconstruction with definitive implant and muscle sparing reconstruction with definitive implant in selected patients. The two techniques are compared in terms of patient quality of life and satisfaction; patient related outcomes, reconstruction morbidity, early and late complications are also investigated.
The study plans to compare conventional submuscular reconstruction with definitive implant and muscle sparing reconstruction with definitive implant in selected patients. The two techniques are compared in terms of patient quality of life and satisfaction; patient related outcomes, reconstruction morbidity, early and late complications are also investigated.
The study plans to collect robust data to support the prepectoral implant placement and complete coverage of implant with acellular dermal matrix in the clinical practice.
Consequently, the project plans to move toward evidence-based medicine in breast reconstruction, avoiding marketing influences and surgeon experience as the sole source of evidence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prepectoral reconstruction | Experimental | Prepectoral breast reconstruction with Braxon dermal matrix |
|
| Submuscular reconstruction | Active Comparator | Submuscolar breast reconstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prepectoral reconstruction | Procedure | Prepectoral breast reconstruction |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction assessed by the BREAST-Q | The BREAST-Q survey is used to detect differences in patient satisfaction among the groups | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate complications rate | Compare post operative complications | 1 month |
| Short term complications rate | Compare short term post operative complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesca De Lorenzi, PhD, MD | European Institute of Oncology | Principal Investigator |
| Paolo Veronesi, MD | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Milan | 20141 | Italy |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Submuscolar reconstruction |
| Procedure |
Submuscolar breast reconstruction |
|
| 6 months |
| Long term complications rate | Compare long term post operative complications | 24 months |
| Percentage of capsular contracture | Compare overall aesthetic outcomes (percentage of capsular contracture) using standardized photographs assessed by independent blinded observers | 1 year |
| D017437 |
| Skin and Connective Tissue Diseases |