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Chlorhexidine bathing and health care-associated infections: a randomized clinical trial.

ABSTRACT: Daily bathing of critically ill patients with the broad-spectrum, topical antimicrobial agent chlorhexidine is widely performed and may reduce health care-associated infections.To determine if daily bathing of critically ill patients with chlorhexidine decreases the incidence of health care-associated infections.A pragmatic cluster randomized, crossover study of 9340 patients admitted to 5 adult intensive care units of a tertiary medical center in Nashville, Tennessee, from July 2012 through July 2013.Units performed once-daily bathing of all patients with disposable cloths impregnated with 2% chlorhexidine or nonantimicrobial cloths as a control. Bathing treatments were performed for a 10-week period followed by a 2-week washout period during which patients were bathed with nonantimicrobial disposable cloths, before crossover to the alternate bathing treatment for 10 weeks. Each unit crossed over between bathing assignments 3 times during the study.The primary prespecified outcome was a composite of central line-associated bloodstream infections (CLABSIs), catheter-associated urinary tract infections (CAUTIs), ventilator-associated pneumonia (VAP), and Clostridium difficile infections. Secondary outcomes included rates of clinical cultures that tested positive for multidrug-resistant organisms, blood culture contamination, health care-associated bloodstream infections, and rates of the primary outcome by ICU.During the chlorhexidine bathing period, 55 infections occurred: 4 CLABSI, 21 CAUTI, 17 VAP, and 13 C difficile. During the control bathing period, 60 infections occurred: 4 CLABSI, 32 CAUTI, 8 VAP, and 16 C difficile. The primary outcome rate was 2.86 per 1000 patient-days during the chlorhexidine and 2.90 per 1000 patient-days during the control bathing periods (rate difference, -0.04; 95% CI, -1.10 to 1.01; P?=?.95). After adjusting for baseline variables, no difference between groups in the rate of the primary outcome was detected. Chlorhexidine bathing did not change rates of infection-related secondary outcomes including hospital-acquired bloodstream infections, blood culture contamination, or clinical cultures yielding multidrug-resistant organisms. In a prespecified subgroup analysis, no difference in the primary outcome was detected in any individual intensive care unit.In this pragmatic trial, daily bathing with chlorhexidine did not reduce the incidence of health care-associated infections including CLABSIs, CAUTIs, VAP, or C difficile. These findings do not support daily bathing of critically ill patients with chlorhexidine.clinicaltrials.gov Identifier: NCT02033187.

SUBMITTER: Noto MJ

PROVIDER: S-EPMC4383133 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Chlorhexidine bathing and health care-associated infections: a randomized clinical trial.

Noto Michael J MJ Domenico Henry J HJ Byrne Daniel W DW Talbot Tom T Rice Todd W TW Bernard Gordon R GR Wheeler Arthur P AP

JAMA 20150101 4

<h4>Importance</h4>Daily bathing of critically ill patients with the broad-spectrum, topical antimicrobial agent chlorhexidine is widely performed and may reduce health care-associated infections.<h4>Objective</h4>To determine if daily bathing of critically ill patients with chlorhexidine decreases the incidence of health care-associated infections.<h4>Design, setting, and participants</h4>A pragmatic cluster randomized, crossover study of 9340 patients admitted to 5 adult intensive care units o ...[more]

PMID: 25602496

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Project description:ImportanceUniversal nasal mupirocin plus chlorhexidine gluconate (CHG) bathing in intensive care units (ICUs) prevents methicillin-resistant Staphylococcus aureus (MRSA) infections and all-cause bloodstream infections. Antibiotic resistance to mupirocin has raised questions about whether an antiseptic could be advantageous for ICU decolonization.ObjectiveTo compare the effectiveness of iodophor vs mupirocin for universal ICU nasal decolonization in combination with CHG bathing.Design, setting, and participantsTwo-group noninferiority, pragmatic, cluster-randomized trial conducted in US community hospitals, all of which used mupirocin-CHG for universal decolonization in ICUs at baseline. Adult ICU patients in 137 randomized hospitals during baseline (May 1, 2015-April 30, 2017) and intervention (November 1, 2017-April 30, 2019) were included.InterventionUniversal decolonization involving switching to iodophor-CHG (intervention) or continuing mupirocin-CHG (baseline).Main outcomes and measuresICU-attributable S aureus clinical cultures (primary outcome), MRSA clinical cultures, and all-cause bloodstream infections were evaluated using proportional hazard models to assess differences from baseline to intervention periods between the strategies. Results were also compared with a 2009-2011 trial of mupirocin-CHG vs no decolonization in the same hospital network. The prespecified noninferiority margin for the primary outcome was 10%.ResultsAmong the 801 668 admissions in 233 ICUs, the participants' mean (SD) age was 63.4 (17.2) years, 46.3% were female, and the mean (SD) ICU length of stay was 4.8 (4.7) days. Hazard ratios (HRs) for S aureus clinical isolates in the intervention vs baseline periods were 1.17 for iodophor-CHG (raw rate: 5.0 vs 4.3/1000 ICU-attributable days) and 0.99 for mupirocin-CHG (raw rate: 4.1 vs 4.0/1000 ICU-attributable days) (HR difference in differences significantly lower by 18.4% [95% CI, 10.7%-26.6%] for mupirocin-CHG, P < .001). For MRSA clinical cultures, HRs were 1.13 for iodophor-CHG (raw rate: 2.3 vs 2.1/1000 ICU-attributable days) and 0.99 for mupirocin-CHG (raw rate: 2.0 vs 2.0/1000 ICU-attributable days) (HR difference in differences significantly lower by 14.1% [95% CI, 3.7%-25.5%] for mupirocin-CHG, P = .007). For all-pathogen bloodstream infections, HRs were 1.00 (2.7 vs 2.7/1000) for iodophor-CHG and 1.01 (2.6 vs 2.6/1000) for mupirocin-CHG (nonsignificant HR difference in differences, -0.9% [95% CI, -9.0% to 8.0%]; P = .84). Compared with the 2009-2011 trial, the 30-day relative reduction in hazards in the mupirocin-CHG group relative to no decolonization (2009-2011 trial) were as follows: S aureus clinical cultures (current trial: 48.1% [95% CI, 35.6%-60.1%]; 2009-2011 trial: 58.8% [95% CI, 47.5%-70.7%]) and bloodstream infection rates (current trial: 70.4% [95% CI, 62.9%-77.8%]; 2009-2011 trial: 60.1% [95% CI, 49.1%-70.7%]).Conclusions and relevanceNasal iodophor antiseptic did not meet criteria to be considered noninferior to nasal mupirocin antibiotic for the outcome of S aureus clinical cultures in adult ICU patients in the context of daily CHG bathing. In addition, the results were consistent with nasal iodophor being inferior to nasal mupirocin.Trial registrationClinicalTrials.gov Identifier: NCT03140423.

Project description:BackgroundCentral line-associated bloodstream infections (CLABSIs) result in approximately 28,000 deaths and approximately $2.3 billion in added costs to the U.S. healthcare system each year, and yet, many of these infections are preventable. At two large health systems in the southeast United States, CLABSIs continue to be an area of opportunity. Despite strong evidence for interventions to prevent CLABSI and reduce associated patient harm, such as use of chlorhexidine gluconate (CHG) bathing, the adoption of these interventions in practice is poor. The primary objective of this study was to assess the effect of a tailored, multifaceted implementation program on nursing staff's compliance with the CHG bathing process and electronic health record (EHR) documentation in critically ill patients. The secondary objectives were to examine the (1) moderating effect of unit characteristics and cultural context, (2) intervention effect on nursing staff's knowledge and perceptions of CHG bathing, and (3) intervention effect on CLABSI rates.MethodsA stepped wedged cluster-randomized design was used with units clustered into 4 sequences; each sequence consecutively began the intervention over the course of 4 months. The Grol and Wensing Model of Implementation helped guide selection of the implementation strategies, which included educational outreach visits and audit and feedback. Compliance with the appropriate CHG bathing process and daily CHG bathing documentation were assessed. Outcomes were assessed 12 months after the intervention to assess for sustainability.ResultsAmong the 14 clinical units participating, 8 were in a university hospital setting and 6 were in community hospital settings. CHG bathing process compliance and nursing staff's knowledge and perceptions of CHG bathing significantly improved after the intervention (p = .009, p = .002, and p = .01, respectively). CHG bathing documentation compliance and CLABSI rates did not significantly improve; however, there was a clinically significant 27.4% decrease in CLABSI rates.ConclusionsUsing educational outreach visits and audit and feedback implementation strategies can improve adoption of evidence-based CHG bathing practices.Trial registrationClinicalTrials.gov, NCT03898115 , Registered 28 March 2019.

Project description:BackgroundChlorhexidine gluconate (CHG) bathing of hospitalized patients may have benefit in reducing hospital-acquired bloodstream infections (HABSIs). However, the magnitude of effect, implementation fidelity, and patient-centered outcomes are unclear. In this meta-analysis, we examined the effect of CHG bathing on prevention of HABSIs and assessed fidelity to implementation of this behavioral intervention.MethodsWe undertook a meta-analysis by searching Medline, EMBASE, CINAHL, Scopus, and Cochrane's CENTRAL registry from database inception through January 4, 2019 without language restrictions. We included randomized controlled trials, cluster randomized trials and quasi-experimental studies that evaluated the effect of CHG bathing versus a non-CHG comparator for prevention of HABSIs in any adult healthcare setting. Studies of pediatric patients, of pre-surgical CHG use, or without a non-CHG comparison arm were excluded. Outcomes of this study were HABSIs, patient-centered outcomes, such as patient comfort during the bath, and implementation fidelity assessed through five elements: adherence, exposure or dose, quality of the delivery, participant responsiveness, and program differentiation. Three authors independently extracted data and assessed study quality; a random-effects model was used.ResultsWe included 26 studies with 861,546 patient-days and 5259 HABSIs. CHG bathing markedly reduced the risk of HABSIs (IRR = 0.59, 95% confidence interval [CI]: 0.52-0.68). The effect of CHG bathing was consistent within subgroups: randomized (0.67, 95% CI: 0.53-0.85) vs. non-randomized studies (0.54, 95% CI: 0.44-0.65), bundled (0.66, 95% CI: 0.62-0.70) vs. non-bundled interventions (0.51, 95% CI: 0.39-0.68), CHG impregnated wipes (0.63, 95% CI: 0.55-0.73) vs. CHG solution (0.41, 95% CI: 0.26-0.64), and intensive care unit (ICU) (0.58, 95% CI: 0.49-0.68) vs. non-ICU settings (0.56, 95% CI: 0.38-0.83). Only three studies reported all five measures of fidelity, and ten studies did not report any patient-centered outcomes.ConclusionsPatient bathing with CHG significantly reduced the incidence of HABSIs in both ICU and non-ICU settings. Many studies did not report fidelity to the intervention or patient-centered outcomes. For sustainability and replicability essential for effective implementation, fidelity assessment that goes beyond whether a patient received an intervention or not should be standard practice particularly for complex behavioral interventions such as CHG bathing.Trial registrationStudy registration with PROSPERO CRD42015032523 .

Project description:BackgroundSurgical site infection is a devastating postoperative complication, and the occurrence ranges from 1% to 2% after total knee arthroplasty (TKA). The efficacy of the preoperative use of chlorhexidine for reducing infection has been debated. This meta-analysis aimed to examine the efficacy of the use of chlorhexidine to prevent surgical site infections after TKA.MethodsIn February 2017, a systematic literature review was conducted using the following electronic databases: PubMed, EMBASE, Web of Science, Cochrane Database of Systematic Reviews, and the Google database. Data from randomized controlled trials (RCTs) and retrospective comparative study (RCS) that compared the use of chlorhexidine versus control washes to prep patients for TKA were retrieved. The primary endpoint was to compare the total incidence of infection with and without the use of chlorhexidine. The secondary outcomes were the incidence of infection in low-risk category patients, moderate-risk category patients, and high-risk category patients. After testing for publication bias and heterogeneity between studies, data were aggregated for random-effects modeling when necessary.ResultsFour clinical trials that included 8787 patients (chlorhexidine group: n = 2615, control group: n = 6172) were ultimately included in the meta-analysis. Chlorhexidine was associated with a reduced total incidence of infection, corresponding to a reduction of 1.69% [risk ratio (RR) = 0.22; 95% confidence interval (95% CI) = 0.12-0.40; P = .000]. Similarly, chlorhexidine was associated with a reduction in the incidence of infection among patients in the moderate-risk category (RR, 0.18; 95% CI, 0.05-0.63; P = .007) and the high-risk category (RR, 0.13; 95% CI, 0.03-0.67; P = .014). There was no significant difference between the incidence of infection in low-risk category patients with chlorhexidine use compared with the use of control washes (RR, 0.60; 95% CI, 0.22-1.60; P = .330).ConclusionThe preoperative use of chlorhexidine could reduce the total incidence of infection and the incidence of infection in moderate-risk and high-risk category patients. The overall evidence and the number of included studies was limited; thus, a greater number of high-quality RCTs is still needed to further identify the effects of chlorhexidine on reducing the incidence of infection after TKA.

Project description:BackgroundUniversal skin and nasal decolonisation reduces multidrug-resistant pathogens and bloodstream infections in intensive care units. The effect of universal decolonisation on pathogens and infections in non-critical-care units is unknown. The aim of the ABATE Infection trial was to evaluate the use of chlorhexidine bathing in non-critical-care units, with an intervention similar to one that was found to reduce multidrug-resistant organisms and bacteraemia in intensive care units.MethodsThe ABATE Infection (active bathing to eliminate infection) trial was a cluster-randomised trial of 53 hospitals comparing routine bathing to decolonisation with universal chlorhexidine and targeted nasal mupirocin in non-critical-care units. The trial was done in hospitals affiliated with HCA Healthcare and consisted of a 12-month baseline period from March 1, 2013, to Feb 28, 2014, a 2-month phase-in period from April 1, 2014, to May 31, 2014, and a 21-month intervention period from June 1, 2014, to Feb 29, 2016. Hospitals were randomised and their participating non-critical-care units assigned to either routine care or daily chlorhexidine bathing for all patients plus mupirocin for known methicillin-resistant Staphylococcus aureus (MRSA) carriers. The primary outcome was MRSA or vancomycin-resistant enterococcus clinical cultures attributed to participating units, measured in the unadjusted, intention-to-treat population as the HR for the intervention period versus the baseline period in the decolonisation group versus the HR in the routine care group. Proportional hazards models assessed differences in outcome reductions across groups, accounting for clustering within hospitals. This trial is registered with ClinicalTrials.gov, number NCT02063867.FindingsThere were 189 081 patients in the baseline period and 339 902 patients (156 889 patients in the routine care group and 183 013 patients in the decolonisation group) in the intervention period across 194 non-critical-care units in 53 hospitals. For the primary outcome of unit-attributable MRSA-positive or VRE-positive clinical cultures (figure 2), the HR for the intervention period versus the baseline period was 0·79 (0·73-0·87) in the decolonisation group versus 0·87 (95% CI 0·79-0·95) in the routine care group. No difference was seen in the relative HRs (p=0·17). There were 25 (<1%) adverse events, all involving chlorhexidine, among 183 013 patients in units assigned to chlorhexidine, and none were reported for mupirocin.InterpretationDecolonisation with universal chlorhexidine bathing and targeted mupirocin for MRSA carriers did not significantly reduce multidrug-resistant organisms in non-critical-care patients.FundingNational Institutes of Health.

Project description:BackgroundChlorhexidine gluconate (CHG) body washes and emollient application may modulate bacterial pathogen colonization and prevent neonatal hospital-acquired infections.MethodsThis pilot, non-randomized, open-label trial, enrolled preterm neonates (1000-1500g; day 1-3 of life) at a tertiary hospital in Cape Town, South Africa. Participants were sequentially allocated to 4 trial arms (n=20 each): 1% aqueous CHG (CHG), 1% CHG plus emollient (CHG+EM), emollient only (EM) and standard of care (SOC: no antiseptic/emollient). Trial treatment/s were applied daily for 10 days (d) post-enrolment, documenting neonatal skin condition score. Anterior nose, neck, umbilical and perianal swabs for bacterial culture were collected at d1, d3, d10 and d16 post-enrolment, (±1 day), reporting pathogen acquisition rates and semi-quantitative bacterial colony counts. (ClinicalTrials.gov identifier: NCT03896893; trial status: closed).FindingsEighty preterm neonates (mean gestational age 30 weeks [SD 2]) were enrolled between 4 March and 26 August 2019. The bacterial pathogen acquisition rate (comparing d1 and d16 swabs) varied from 33·9% [95%CI 22·9-47·0] at the umbilicus, 39·3% [95%CI 27·6-52·4] at the neck, to 71·4% [95%CI 58·5-81·7] at both the nose and perianal region. At d10, CHG babies had reduced bacterial density detected from neck, umbilicus, and perianal swabs compared to other groups (see Table 3). Following intervention cessation, colonization density was similar across all trial arms, but S. aureus colonization was more prevalent among EM and CHG+EM babies. Neonatal skin condition score improved in babies receiving emollient application (EM: -0·87 [95%CI 0·69-1·06] and CHG+EM: -0·73 [0·45-0·99]), compared to the SOC and CHG arms (Table 2); no CHG-related skin reactions occurred.InterpretationBacterial colonization density was significantly reduced in babies receiving 1% CHG washes but colonization levels rebounded rapidly post-intervention. Emollient application improved skin condition but was associated with higher rates of S. aureus colonization.FundingSouth African Medical Research Council; National Institutes of Health (TW010682).

Dataset Information

Chlorhexidine bathing and health care-associated infections: a randomized clinical trial.

Publications

Chlorhexidine bathing and health care-associated infections: a randomized clinical trial.

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