ABSTRACT
BACKGROUND: The current simulators for teaching oncoplastic surgery marking are available in a fixed size for each model. This is not an accurate reflection of the variety of patient's breast volumes in reality and may limit the teaching to certain techniques associated with the particular breast ptosis/size. DEVICE DESCRIPTION: This is the first reported simulator with varying breast volumes/ptosis in a single model for teaching oncoplastic surgery marking, known as Adjustable Breast Oncoplastic Surgery Simulator (ABOSS). Adjustable Breast Oncoplastic Surgery Simulator was created using 3D printing. PRELIMINARY RESULTS: Adjustable Breast Oncoplastic Surgery Simulator could simulate the breast in appearance and texture. It is inexpensive and allows the practice of various markings based on the different breast volumes/ptosis in a single model. It also allows for the practice of the marking needed in asymmetric breasts to correct the asymmetry. CURRENT STATUS: Plans for commercialisation were made.
Subject(s)
Breast Neoplasms , Mammaplasty , Humans , Female , Mammaplasty/methods , Mastectomy, Segmental/methods , Mastectomy/methods , Breast/surgery , Printing, Three-Dimensional , Breast Neoplasms/surgeryABSTRACT
Importance: Three-dimensionally printed nasopharyngeal swabs (3DP swabs) have been used to mitigate swab shortages during the coronavirus disease 2019 (COVID-19) pandemic. Clinical validation for diagnostic accuracy and consistency, as well as patient acceptability, is crucial to evaluate the swab's performance. Objective: To determine the accuracy and acceptability of the 3DP swab for identifying severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Design, Setting, and Participants: A diagnostic study was conducted from May to July 2020 at 2 tertiary care centers in Singapore with different reference swabs (FLOQSwab [COPAN Diagnostics] or Dacron swab [Deltalab]) and swab processing techniques (wet or dry) to evaluate the performance of the 3DP swab compared with traditional, standard-of-care nasopharyngeal swabs used in health care institutions. The participants were patients with COVID-19 in the first 2 weeks of illness and controls with acute respiratory illness with negative test results for SARS-CoV-2. Paired nasopharyngeal swabs were obtained from the same nostril and tested for SARS-CoV-2 by reverse-transcriptase polymerase chain reaction. The sequence of swabs was randomized based on odd and even participant numbers. Main Outcomes and Measures: Primary outcome measures were overall agreement (OA), positive percentage agreement (PPA), and negative percentage agreement of the 3DP swab compared with reference swabs. Secondary outcome measures were the correlation of cycle threshold (Ct) values of both swabs. Results: The mean (SD) age of participants was 45.4 (13.1) years, and most participants were men (87 of 89 [97.8%]), in keeping with the epidemiology of the COVID-19 pandemic in Singapore. A total of 79 patients with COVID-19 and 10 controls were recruited. Among the patients with COVID-19, the overall agreement and PPA of the 3DP swab was 91.1% and 93.5%, respectively, compared with reference swabs. The PPA was 100% for patients with COVID-19 who were tested within the first week of illness. All controls tested negative. The reverse-transcriptase polymerase chain reaction Ct values for the ORF1ab and E-gene targets showed a strong correlation (intraclass correlations coefficient, 0.869-0.920) between the 3DP and reference swab on independent testing at each institution despite differences in sample processing. Discordant results for both gene targets were observed only at high Ct values. Conclusions and Relevance: In this diagnostic study of 79 patients with COVID-19 and 10 controls, the 3DP swab performed accurately and consistently across health care institutions and could help mitigate strained resources in the escalating COVID-19 pandemic.