2 research outputs found

    Diseño de una férula de muñeca impresa en 3D con soporte para un exoesqueleto de los dedos de la mano.

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    El presente Trabajo de Fin de Grado pretende llegar a marcar un antes y un después en la evolución y desarrollo de férulas ortopédicas, un material sanitario que a nivel económico no se encuentra disponible para un amplio marco de la población y cuyos materiales dificultan su uso. Con este proyecto se pretende crear una férula dinámica de muñeca con un amplio número de funciones para pacientes con problemas de movilidad, cognitivos, posibles fisuras y, especialmente, en pacientes con rotura de tendones flexores de los dedos de la mano. El motivo del enfoque centrado en esta última premisa es el elevado porcentaje de operaciones de tendones causados por cortes en el trabajo manual y es que, a pesar de esto, hoy en día todavía no hay disponible un sistema de ayuda y rehabilitación postoperatorio específico. Además, esta férula está al alcance de toda la población gracias a su bajo coste, aporta gran calidad de comodidad gracias a su elevada ligereza conseguida por medio del uso de impresión aditiva y tiene un diseño muy sencillo que permite ser usado sin limitación alguna de conocimientos específicos. Gracias a su diseño modular se ha conseguido también un producto sostenible, cuyas piezas pueden ser recicladas por separado y sustituidas de manera individual sin necesidad de desperdiciar la ortesis completamente en caso de fisuras o roturas. Cabe destacar que su posibilidad de personalización mejorará la calidad del proceso de rehabilitación reflejándose, por consiguiente, en una mejora de la calidad de vida del pacient

    Subcutaneous anti-COVID-19 hyperimmune immunoglobulin for prevention of disease in asymptomatic individuals with SARS-CoV-2 infection: a double-blind, placebo-controlled, randomised clinical trialResearch in context

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    Summary: Background: Anti-COVID-19 hyperimmune immunoglobulin (hIG) can provide standardized and controlled antibody content. Data from controlled clinical trials using hIG for the prevention or treatment of COVID-19 outpatients have not been reported. We assessed the safety and efficacy of subcutaneous anti-COVID-19 hyperimmune immunoglobulin 20% (C19-IG20%) compared to placebo in preventing development of symptomatic COVID-19 in asymptomatic individuals with SARS-CoV-2 infection. Methods: We did a multicentre, randomized, double-blind, placebo-controlled trial, in asymptomatic unvaccinated adults (≥18 years of age) with confirmed SARS-CoV-2 infection within 5 days between April 28 and December 27, 2021. Participants were randomly assigned (1:1:1) to receive a blinded subcutaneous infusion of 10 mL with 1 g or 2 g of C19-IG20%, or an equivalent volume of saline as placebo. The primary endpoint was the proportion of participants who remained asymptomatic through day 14 after infusion. Secondary endpoints included the proportion of individuals who required oxygen supplementation, any medically attended visit, hospitalisation, or ICU, and viral load reduction and viral clearance in nasopharyngeal swabs. Safety was assessed as the proportion of patients with adverse events. The trial was terminated early due to a lack of potential benefit in the target population in a planned interim analysis conducted in December 2021. ClinicalTrials.gov registry: NCT04847141. Findings: 461 individuals (mean age 39.6 years [SD 12.8]) were randomized and received the intervention within a mean of 3.1 (SD 1.27) days from a positive SARS-CoV-2 test. In the prespecified modified intention-to-treat analysis that included only participants who received a subcutaneous infusion, the primary outcome occurred in 59.9% (91/152) of participants receiving 1 g C19-IG20%, 64.7% (99/153) receiving 2 g, and 63.5% (99/156) receiving placebo (difference in proportions 1 g C19-IG20% vs. placebo, −3.6%; 95% CI -14.6% to 7.3%, p = 0.53; 2 g C19-IG20% vs placebo, 1.1%; −9.6% to 11.9%, p = 0.85). None of the secondary clinical efficacy endpoints or virological endpoints were significantly different between study groups. Adverse event rate was similar between groups, and no severe or life-threatening adverse events related to investigational product infusion were reported. Interpretation: Our findings suggested that administration of subcutaneous human hyperimmune immunoglobulin C19-IG20% to asymptomatic individuals with SARS-CoV-2 infection was safe but did not prevent development of symptomatic COVID-19. Funding: Grifols
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