Cell-free biomimetic polyurethane-based scaffold for breast reconstruction following non-malignant lesion resection. A first-in-human study.

Autor: Mariniello MD; Breast Cancer Center, University Hospital of Pisa, Via Roma 57, 56126, Pisa, Italy. m.d.mariniello@gmail.com., Ghilli M; Breast Cancer Center, University Hospital of Pisa, Via Roma 57, 56126, Pisa, Italy., Favati B; Breast Radiology, Breast Cancer Center, University Hospital of Pisa, Via Roma 57, 56126, Pisa, Italy., Gerges I; Tensive SRL, Via Timavo 34, Milan, Italy., Colizzi L; Breast Cancer Center, University Hospital of Pisa, Via Roma 57, 56126, Pisa, Italy., Tamplenizza M; Tensive SRL, Via Timavo 34, Milan, Italy., Tocchio A; Tensive SRL, Via Timavo 34, Milan, Italy., Martello F; Tensive SRL, Via Timavo 34, Milan, Italy., Ghilardi M; Breast Cancer Center, University Hospital of Pisa, Via Roma 57, 56126, Pisa, Italy., Cossu MC; Breast Radiology, Breast Cancer Center, University Hospital of Pisa, Via Roma 57, 56126, Pisa, Italy., Danti S; Department of Civil and Industrial Engineering, University of Pisa, Largo L. Lazzarino 2, 56122, Pisa, Italy.; Department of Civil and Environmental Engineering, Massachusetts Institute of Technology, 77 Massachusetts Ave., Cambridge, MA, 02139, USA., Roncella M; Breast Cancer Center, University Hospital of Pisa, Via Roma 57, 56126, Pisa, Italy.
Jazyk: angličtina
Zdroj: Breast cancer (Tokyo, Japan) [Breast Cancer] 2023 Jul; Vol. 30 (4), pp. 559-569. Date of Electronic Publication: 2023 Mar 28.
DOI: 10.1007/s12282-023-01446-5
Abstrakt: Background: Based on the volume of tissue removed, conservative surgery (BCS) cannot always guarantee satisfactory cosmetic results, unless resorting to more complex oncoplastic approaches. Investigating an alternative to optimize aesthetic outcomes minimizing surgical complexity, was the purpose of this study. We assessed an innovative surgical procedure based on the use of a biomimetic polyurethane-based scaffold intended for regenerating soft-tissue resembling fat, in patients undergoing BCS for non-malignant breast lesions. Safety and performance of the scaffold, and safety and feasibility of the entire implant procedure were evaluated.
Methods: A volunteer sample of 15 female patients underwent lumpectomy with immediate device positioning, performing seven study visits with six-month follow-up. We evaluated incidence of adverse events (AEs), changes in breast appearance (using photographs and anthropomorphic measurements), interference with ultrasound and MRI (assessed by two independent investigators), investigator's satisfaction (through a VAS scale), patient's pain (through a VAS scale) and quality of life (QoL) (using the BREAST-Q© questionnaire). Data reported are the results of the interim analysis on the first 5 patients.
Results: No AEs were device related nor serious. Breast appearance was unaltered and the device did not interference with imaging. High investigator's satisfaction, minimal post-operative pain and positive impact on QoL were also detected.
Conclusions: Albeit on a limited number of patients, data showed positive outcomes both in terms of safety and performance, paving the way to an innovative breast reconstructive approach with a potential remarkable impact on clinical application of tissue engineering.
Trial Registration: ClinicalTrials.gov (NCT04131972, October 18, 2019).
(© 2023. The Author(s), under exclusive licence to The Japanese Breast Cancer Society.)
Databáze: MEDLINE
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