Nome e qualifica del proponente del progetto: 
sb_p_1594856
Anno: 
2019
Abstract: 

Increasingly affordable three-dimensional (3D) printing technologies now make it possible for surgeons to create highly customizable patient tailored products. This process provides the potential to produce individualized artificial and biologic implants, regenerative scaffolds, and cell-specific replacement tissue and organs.
A range of standardized breast implants with different profiles, shapes, and sizes are commercially available; however, they may not be well suited for all patients. Multiple studies have confirmed that most women have some degree of breast asymmetry in up to 81% to 88%. Postmastectomy patients seeking reconstructive surgeries have even more discernible differences that may prove to be an added challenge in creating a consistently balanced appearance.
These findings underscore the importance and emphasize the need for a customized breast implant that can more accurately compliment anatomical variations to produce more uniform aesthetic.
The ideal implant for breast reconstruction should be a biological implant with natural feel, customized proportions and projection, as well as utilization of denser biologic substrates such as collagen. 3D-printing is a form of additive or subtractive manufacturing, which is a precise computer-controlled process where either successive layering of material is deposited to produce a 3D end product. This process provides the potential to produce everything from artificial and biologic implants, regenerative scaffolds to cell-specific replacement tissue and organs. The aim of this project is to evaluate the outcomes in using 3D printed custom made silicon breast implant in patient undergoing immediate prepectoral breast reconstruction and compare the results with patients undergoing prepectoral breast reconstruction with standard silicon gel implant and ADM (dermal acellular matrix) and patients undergoing immediate breast autologous reconstruction with DIEP (Deep inferior epigastric perforator) flap.

ERC: 
SH1_11
LS7_10
SH1_11
Componenti gruppo di ricerca: 
sb_cp_is_2234305
sb_cp_is_2251318
Innovatività: 

3D printing has been utilized in industrial design since the 1980s; however, it has only become adapted for medical application in the last decade. Imaging data from routine CT or MRI can be converted into a CAD file using a variety of 3D software programs. These files are processed into data slices suitable for printing by proprietary softwares from the 3D printer manufacturers. Clinically, 3D-printed biomodels provide a tactile feedback and enable users to simulate complex anatomical movements. As a result, they facilitate an enhanced appreciation of the visuospatial relationship between anatomical structures for the surgeons. In preoperative planning, 3D-printed biomodels have been beneficial in orbital and mandibular reconstruction in maxillofacial surgery; in preoperative soft tissue and vascular mapping. 3D printing has enabled rapid and convenient production of customized implants. Investigators have manufactured patient-specific mandibular implants, cranial vault implants, hip implants , and a bioresorbable airway splint. For breast surgery analysis of 3D imaging provides personalized consideration of variations in anatomy, such as muscular and skeletal asymmetries, that may cause unexpected aesthetic outcomes. The current standard for preoperative evaluation in selecting appropriate implant involves the use of 2D photography and visual estimation. 3D imaging provided a useful tool for more accurate volume measurements and shape analysis. The technique assists in determining the causes of asymmetry and helps guide reconstruction prior to surgery. Concurrent contrast use provides preoperative identification of vascular anatomical variations and assesses perforator locations for deep inferior epigastric perforators. In addition to aiding in preoperative planning, data from imaging can then be used in the digital reconstructions necessary for 3D printed implant fabrication.
A range of standardized breast implants with different profiles, shapes, and sizes are commercially available; however, they may not be well suited for all patients. Multiple studies have confirmed that most women have some degree of breast asymmetry with some large series reporting noticeable breast asymmetry in up to 81% to 88% of their patient population. Breast asymmetries could arise secondarily to underlying bone or soft tissue abnormalities of the thoracic chest wall. Considering the overall prevalence of breast asymmetry, literature has also demonstrated significant corresponding postoperative discrepancies in breast size and shape after mammaplasty procedures. Authors note that preexisting asymmetries often times will produce more pronounced differences postoperatively even with the use of initial corrective measures. These findings underscore the importance and emphasize the need for a customized breast implant that can more accurately compliment anatomical variations to produce more uniform aesthetic outcomes for individuals who do not fit within the standard range of implant sizes or who have noticeable breast asymmetries.
Postmastectomy patients seeking reconstructive surgeries have even more discernible differences that may prove to be an added challenge in creating a consistently balanced appearance. Often times, the underlying cause of the asymmetry is difficult to assess clinically.
Preoperative 3D imaging, is beneficial in these situations. In addition to providing precisely shaped implants for patients, 3D printing also allows physicians the ability to produce implants with stratified density layering. Additive printing has the capability of using variable density substrates that can then be layered in a particular order with the added option of using different surface textures to create a totally integrated single-component implant. This allows for a more proportional correction of asymmetries with particular densities assigned to match the fraction of analogous soft tissue and/or chest wall differences. This technology provides the potential to create superior aesthetic outcomes and more natural tactile implant qualities as a result of individual tailoring to accommodate the patient's anatomical needs.
The aim of this project is to evaluate the outcomes in using 3D printed custom made silicon breast implant in patient undergoing immediate prepectoral breast reconstruction after skin sparing mastectomy. The custom made implant will be created using a specific silicon 3D printer which uses a base silicone medical oil, adding a cross linker for softening the rubber and then adding a catalyst to accelerate the curing process without the need for support materials and any post processing methods. The results will be compared with the results of other surgical reconstructive procedure to evaluate if 3D reconstruction is really the future of breast reconstruction.
The future aim is to develop biologic 3D customized breast implants with natural feel, customized proportions and projection.

Codice Bando: 
1594856

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