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Randomized Controlled Trial
. 2024 Dec;50(12):2073-2082.
doi: 10.1007/s00134-024-07667-2. Epub 2024 Oct 17.

EFFECT of daily antiseptic bathing with octenidine on ICU-acquired bacteremia and ICU-acquired multidrug-resistant organisms: a multicenter, cluster-randomized, double-blind, placebo-controlled, cross-over study

Tiffany Schaumburg #  1 , Norbert Köhler #  2 , Yasmine Breitenstein  2 , Susanne Kolbe-Busch  3 , Dirk Hasenclever #  4 , Iris F Chaberny #  3   5
Affiliations
Randomized Controlled Trial

EFFECT of daily antiseptic bathing with octenidine on ICU-acquired bacteremia and ICU-acquired multidrug-resistant organisms: a multicenter, cluster-randomized, double-blind, placebo-controlled, cross-over study

Tiffany Schaumburg et al. Intensive Care Med. 2024 Dec.

Erratum in

Abstract

Purpose: Antiseptic bathing has garnered attention in an effort to reduce hospital-acquired infections. Previous studies have shown the efficacy of antiseptic bathing in high-risk environments, such as intensive care units (ICUs), using chlorhexidine. In this study we aimed to evaluate the effectiveness of octenidine as a potential alternative due to its established popularity and widespread use in Europe.

Methods: We compared the rates of ICU-acquired primary bacteremia and ICU-acquired multidrug-resistant organisms (MDROs) in a multicenter, cluster-randomized, double-blind, placebo-controlled, cross-over study using octenidine-impregnated and placebo washcloths. On 44 ICUs in 23 hospitals throughout Germany, we compared individual ICUs with themselves over two 12-month time periods. All data were obtained digitally via hospital information systems as individual ward-movement data and microbiological test results; both endpoints were algorithmically derived.

Results: 104,039 ICU episodes from 93,438 patients with 712,784 microbiological test results were analyzed, thereby detecting 1508 cases of ICU-acquired primary bacteremia and 1871 cases of ICU-acquired MDRO. Bathing with octenidine-impregnated washcloths prevented ICU-acquired primary bacteremia; a risk reduction of 17% was seen homogeneously across all participating ICUs (adjusted hazard ratio (HR) 0.83, 95% confidence interval (CI) [0.75; 0.92], p = 0.0003). This reduction affected predominantly coagulase-negative staphylococci (53%) and enterococci (17%). However, no intervention effect was seen for ICU-acquired MDROs (adjusted HR 0.98, 95% CI [0.83; 1.15]). Heterogeneity among intra-ICU intervention effects on MDRO acquisition was substantial.

Conclusions: Antiseptic bathing with octenidine may be effective in preventing ICU-acquired primary bacteremia, particularly due to Gram-positive bacteria and common skin commensals.

Keywords: Antiseptic bathing; Bacteremia; Intensive care unit; Multidrug-resistant organisms; Octenidine.

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Conflict of interest statement

Declarations. Conflicts of interest: The author(s) declare no competing interests. Ethics statement: This study was approved by the ethics committee at the University of Leipzig (340/16-ek). Informed consent on the patients’ part was deemed unnecessary and, therefore, not required for study participation. Data sharing: The study protocol (in German) and the statistical analysis plan are available. Study data that underlie the results reported in this article (text, tables, figures and appendices) will be shared to researchers who provide a methodologically sound and ethically approved proposal. Proposals can be submitted up to at least 36 months after article publication. Proposals should be directed to norbert.koehler@zks.uni-leipzig.de; to gain access, data requestors will need to sign a data-access agreement.

Figures

Fig. 1
Fig. 1
Study design. The EFFECT trial was a multicenter, cluster-randomized, double-blind, placebo-controlled, cross-over study in which ICUs were the units of randomization. An AB/BA cross-over design was used in order to compare single ICUs to themselves. Each ICU participated in two 12-month intervention periods, both preceded by a 3-month wash-out period; the total study duration for a single ICU was 30 months. ICUs were randomized by starting with either green (octenidine) or blue (placebo) washcloth packages in order to average out a possible period effect. ICU intensive care unit
Fig. 2
Fig. 2
Treatment episodes flow chart. In the two 12-month intervention periods, we gathered 104,039 ICU episodes from 93,438 patients; microbiological data for these patients consisted of test results for 712,784 specimens. 44,022 ICU episodes (42.3%) had a length of  > 2 calendar days and were considered potentially informative for both co-primary endpoints. For each endpoint, we restricted analysis to informative episodes in which the respective event had not already been documented during the entire hospital stay up to day 3. The two co-primary endpoint analyses are based on N = 1508 ICU-acquired primary bacteremia in 41,058 episodes from 38,440 patients and N = 1871 ICU-acquired MDRO in 40,149 episodes from 37,804 patients. ICU intensive care unit, MDRO multidrug-resistant organism
Fig. 3
Fig. 3
Forest plots. Forest plots for each of the two co-primary endpoints visualize the heterogeneity of the treatment effect across ICUs. For each of the 44 participating ICUs, a point estimate for the intervention effect within each ICU is shown (as log HR) with 95% confidence intervals. Estimates are based on separate, simple, fixed-effect Cox models within each ICU. The color (green/blue) indicates the starting intervention to which the ICUs were randomized. The diamond-shaped summary estimates and confidence intervals are derived from the respective overall mixed-effects Cox regression model. The heterogeneity is negligible for ICU-acquired bacteremia, whereas it is substantial and clearly visible for ICU-acquired MDROs. CI confidence interval, HR hazard ratio, MDRO multidrug-resistant organism
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