Ensayo clínico aleatorizado para la comparación de dos métodos de cura de traqueotomía en una Unidad de Cuidados Intensivos

Abstract

IntroductionTracheotomy is a common technique in Intensive Care Units (ICU). It is known that nursing care during and after that procedure is directly related to its success, by reducing the possible complications to a minimum, such as the stoma infection, and contributing to a favourable outcome in critical patients. ObjectivesTo compare the use of polyhexanide (PLX) versus saline+povidone iodine (PY) as antiseptics and infection incidence in tracheostomies performed in Intensive Care Units. Material and methodA 2-year, experimental, randomised, open-label trial carried out in a multidiscipline ICU with 32 beds. The study was approved by the Research Ethics Committee of Principality of Asturias. ResultsThe overall infection rate observed for every hundred patients was 1.34 (95% CI; 0.81-2.01), with 1.46 when using PLX and 1.21 for PY (P=.685). ConclusionsIn spite of the experimental treatment (PLX) was shown to be effective in other types of wounds in our study. No significant differences were found between this technique and the standard one. Since there is no national registry of tracheotomy- associated infections, it is not possible to know whether the rate observed is within the usual parameters.