EFFECT of daily washing with Octenidine impregnated wash-cloths on the incidence of nosocomial infections in intensive care - a cross-over trial randomising intensive care units.
Medical Microbiology and Mycology, Hygiene, Molecular Infection Biology
Final Report Abstract
EFFECT was a placebo-controlled, cluster-randomised, double-blind study carried out in crossover design that aimed to analyse the effect of daily antiseptic bathing with octenidine on hospital-acquired primary bacteremia and hospital-acquired multidrug-resistant organisms. Carried out on 44 intensive care units in 23 hospitals throughout Germany, EFFECT compared two sets of pre-packaged washcloths – one containing octenidine-infused washcloths, while the other contained a placebo. By carrying out the study in crossover design, each participating ICU was compared with itself over a total time period of 30 months. In two intervention phases – one for each washcloth set – both a 3-month wash-out phase and a 12-month active intervention phase were carried out. Data acquisition from each participating hospital was conducted digitally with routine data acquired from hospital and laboratory information systems. Two sets of data – on the one hand ward-movement history and on the other hand microbiological test results – were gathered from on-site personnel and sent in anonymous form to the Clinical Trial Centre Leipzig, where they were linked and analysed via algorithm to determine whether an infection was nosocomial in nature. After analysing the data from all of the 44 participating ICUs, which included ward-movement data and microbiological test results from 93,438 patients, and filtering for informative treatment episodes that were more than two calendar days in length, EFFECT came to the following conclusions: There is a highly statistically significant intervention effect on hospitalacquired primary bacteremia when using octenidine-infused washcloths for daily antiseptic bathing on intensive care units, with a risk reduction of 17% and a p-value of 0.00032. Detailed statistical analyses show a difference in the types of pathogens most effectively targeted by daily antiseptic bathing with octenidine-infused washcloths; statistically significant reduction effects were seen not only with common commensals (coagulase-negative Staphylococci) but also with other gram-positive pathogens, such as Enterococci and Staphyloccus aureus. This intervention effect was, however, not statistically significant when analyzing gram-negative pathogenic organisms. As for hospital-acquired MDROs, however, no such intervention effect was seen, with a statistically non-significant p-value of 0.7869. Given that no intervention effect was seen with multidrug-resistant organisms, we postulate that the situation surrounding the acquisition of MDROs is a multifaceted challenge that is best tackled with bundled solutions as opposed to one solitary prevention measure.
Publications
- EFFECT of daily antiseptic body wash with octenidine on nosocomial primary bacteraemia and nosocomial multidrug-resistant organisms in intensive care units: design of a multicentre, clusterrandomised, double-blind, cross-over study. BMJ Open. 2017;7(11):e016251
Meißner A, Hasenclever D, Brosteanu O, Chaberny IF
(See online at https://dx.doi.org/10.1136/bmjopen-2017-016251)
