Development and clinical application of an original radio-opaque ink for use as a marker in radiological diagnosis and radioscopy-assisted Orthopedics and Traumatology surgeries (Q3182126): Difference between revisions
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(Created claim: summary (P836): Objective: Optimisation and study of usefulness of a chemical compound patented by our group, whose use as a radio-opaque marker ink is a novelty in the field of biomedicine. Design: From this compound already developed, in a first phase will be carried out laboratory chemical tests to determine its optimal composition, the most practical applicator and the most effective protocol of use on simulation fantoms of the human body, for validation...) |
(Changed label, description and/or aliases in en: translated_label) |
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Development and clinical application of an original radio-opaque ink for use as a marker in radiological diagnosis and radioscopy-assisted Orthopedics and Traumatology surgeries | |||
Revision as of 19:21, 12 October 2021
Project Q3182126 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | Development and clinical application of an original radio-opaque ink for use as a marker in radiological diagnosis and radioscopy-assisted Orthopedics and Traumatology surgeries |
Project Q3182126 in Spain |
Statements
6,175.0 Euro
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12,350.0 Euro
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50.0 percent
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1 January 2014
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31 March 2018
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INSTITUTO ARAGONES DE CIENCIAS DE LA SALUD
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41°39'7.67"N, 0°52'51.38"W
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50297
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Objetivo: Optimización y estudio de utilidad de un compuesto químico patentado por nuestro grupo, cuyo uso como tinta marcadora radio-opaca supone una novedad en el campo de la biomedicina. Diseño: A partir de este compuesto ya desarrollado, en una primera fase se realizarán ensayos químicos de laboratorio para determinar su composición óptima, el aplicador más práctico y el protocolo de uso más eficaz sobre fantomas de simulación del cuerpo humano, para su validación como marcador en estudios radiográficos estándar. En una segunda fase, se realizará un estudio longitudinal prospectivo de pacientes (N= 200) con patología traumatológica en Urgencias y Quirófanos de Traumatología, para determinar su utilidad “in vivo”. Se exigirá consentimiento informado en todos los casos y autorización del Comité de Bioética. La asignación al grupo de estudio se hará de forma aleatoria. En el grupo “Casos” se aplicará de manera controlada la tinta radio-opaca para los estudios radiológicos e intervenciones quirúrgicas y se comparará con un grupo de “Controles” en los que será aplicada otra tinta no radio-opaca “placebo”. Se analizarán indicadores de mejoría en la eficacia del diagnóstico radiológico y en la técnica quirúrgica, de acortamiento en los tiempos quirúrgicos y de disminución de la exposición a radiación de pacientes y personal sanitario, con el uso del nuevo marcador. Instrumentos-determinaciones Se utilizarán instrumentos y criterios diagnósticos con fiabilidad documentada, y clasificaciones oficiales como AO/ASIF de fracturas o la Escala Visual Analógica del dolor . La eficacia diagnóstica será evaluada por un panel de expertos “ciegos” a la intervención. (Spanish)
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Objective: Optimisation and study of usefulness of a chemical compound patented by our group, whose use as a radio-opaque marker ink is a novelty in the field of biomedicine. Design: From this compound already developed, in a first phase will be carried out laboratory chemical tests to determine its optimal composition, the most practical applicator and the most effective protocol of use on simulation fantoms of the human body, for validation as a marker in standard radiographic studies. In a second phase, a prospective longitudinal study of patients (N=200) with traumatic pathology in the ER and Traumatology Operators will be carried out to determine their usefulness “in vivo”. Informed consent shall be required in all cases and authorisation of the Bioethics Committee. Assignment to the study group shall be done at random. In the case group, radio-opaque ink shall be applied in a controlled manner for radiological studies and surgical interventions and compared with a group of “Controls” in which another non-radio-opaque “placebo” ink will be applied. Indicators of improvement in the effectiveness of radiological diagnosis and surgical technique, shortening in surgical times and reduction of radiation exposure of patients and healthcare personnel will be analysed, with the use of the new marker. Instruments-determinations Diagnostic instruments and criteria will be used with documented reliability, and official classifications such as AO/ASIF fractures or the Analog Visual Pain Scale. The diagnostic effectiveness will be evaluated by a panel of experts “blind” to the intervention. (English)
12 October 2021
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Zaragoza
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Identifiers
PI13_01359
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