Scandinavian Journal of Infectious Diseases, 2014; 46: 697–703
ORIGINAL ARTICLE
Weekly chlorhexidine douche: does it reduce healthcare-associated bloodstream infections?
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DERYA SEYMAN1, NEFISE OZTOPRAK1, HANDE BERK1, FILIZ KIZILATES1 & MESTAN EMEK2 1Antalya
Education and Research Hospital, Department of Infectious Diseases and Clinical Microbiology and 2Public Health Institution, Department of Public Health and Epidemiology, Antalya, Turkey
Abstract Background: Daily chlorhexidine (CHG) bathing has been used as a precaution to reduce the rate of healthcare-associated bloodstream infections (HA-BSI). The application frequency of CHG bathing remains unclear, this procedure has been implemented daily by this time. The aim of this study was to determine the efficacy of weekly whole-body douche with CHG shower gel on rates of HA-BSI. Methods: We conducted a prospective intervention trial in medical, surgical, and anesthesiology intensive care units (ICUs) in a tertiary teaching hospital from June 2011 to November 2012. This study included three periods. During the first period, patients received a daily bed bath by wiping with water and soap. In the second period patients were given a weekly douche with water and soap; in the third period patients were given a weekly douche with CHG shower gel. The rates of HA-BSI were compared between the three periods using Poisson regression analysis. Results: The central line-associated bloodstream infection rates did not decline significantly between periods (p ⫽ 0.76). The laboratory-confirmed bloodstream infection (LCBSI) rates in the first, second, and third periods were 7.1, 4, and 1.7, respectively. The LCBSI rates were reduced 43.7% from the first period to the second period (p ⫽ 0.03). In addition, there was a 57.5% reduction in LCBSI rates between the second and third periods (p ⬍ 0.001). Interestingly, the major decline (76.1%) was determined from the first to the third period (p ⬍ 0.002). Conclusions: Weekly douche with CHG shower gel significantly reduced LCBSI rates. Further studies are needed to validate the clinical impact of different intervals of CHG bathing.
Keywords: Weekly douche, chlorhexidine shower gel, bloodstream infection
Introduction Healthcare-associated bloodstream infections (HABSIs) are a serious problem among the critically ill patients admitted to intensive care units (ICUs), which are often associated with higher morbidity and mortality rates and increased lengths of stay, as well as additional medical cost of care in this population [1]. These infections are a serious threat to patient safety in the ICUs. It is believed that most episodes of HA-BSI are preventable. The majority of these infections are associated with the use of a central venous catheter (CVC) and are called central lineassociated bloodstream infections (CLABSIs). The risks of developing HA-BSI depend on certain factors such as type of ICU, appropriate hospital infrastructure, quality of patient care, and practical implementation of preventive steps to reduce CLABSI.
The prevention of HA-BSI is a vital component in the management of critically ill patients. Several approaches for the prevention of HA-BSI have been proposed, including the use of central line care bundles, specific practical measures such as hand hygiene in healthcare workers (HCWs), maximal barrier precautions for catheter insertion (use of cap, mask, sterile gloves, full sleeved sterile gown, and large sterile drapes), and preferential use of the subclavian site for CVC insertion [2,3]. Different studies conducted on these topics have reported improvement in the rates of HA-BSI, especially CLABSI. However, a limited number of studies have recorded near-zero rates for CLABSI [4–7]. Furthermore, the economic burden of these infections is high and a reduction in these rates would be advantageous for healthcare facilities [8]. In particular, in Turkey, the
Correspondence: Derya Seyman MD Specialist, Antalya Eg˘itim ve Aras¸tırma Hastanesi, Enfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Klinig˘i, 07100 Antalya, Turkey. Tel: ⫹ 90 242 249 34 25. Fax: ⫹ 90 242 249 44 62. E-mail: [email protected] (Received 16 April 2014 ; accepted 30 May 2014 ) ISSN 0036-5548 print/ISSN 1651-1980 online © 2014 Informa Healthcare DOI: 10.3109/00365548.2014.931597
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rates of HA-BSI are indicators of a hospital’s quality performance criteria. The bacterial colonization of the skin plays a large role in the pathogenesis of HA-BSI. The portal of bacterial entry into the bloodstream is probably from impairments in skin entirety caused by invasive devices [2]. Therefore, some authors have suggested a new approach targeting universal decolonization strategies such as daily bathing with chlorhexidine gluconate (CHG) to reduce skin microbial bioburden [9]. It has been shown that the use of CHG bathing is associated with a significant decrease in HA-BSI rates, especially CLABSI, and in skin colonization with multidrug-resistant organisms in adult ICU patients [10–15]. Based on these observations, CHG bathing is a reasonable approach for decolonization of the whole body in routine daily ICU patient care skills. CHG is a potent antiseptic agent in widespread use in medical care. It is used in preoperative skin cleansing preparations, hand disinfectants, oral mouth rinses, and skin antiseptic, as it is efficacious against gram-positive and -negative bacteria [16]. There are various kinds of products with CHG in clinical practice, such as solution, soap or gels and washcloths impregnated or saturated with CHG [17]. Most of the studies performed in ICUs include using a daily CHG bathing system with CHGimpregnated washcloths without rinsing. In the literature, there are few studies using CHG solution and only one study evaluating the effect of weekly CHG bathing, which was performed at a long-term acute care hospital [12,18,19]. In the present study, we assessed the influence of a weekly douche with CHG shower gel on the rate of HA-BSI in ICUs.
Setting and patients Antalya Education and Research Hospital is a 1000bed, tertiary teaching hospital with about 67 921 admissions annually in Antalya, Turkey. The hospital has a 12-bed adult ICU run by the Anaesthesiology Department, a 9-bed medical ICU for medical patients, and a 12-bed surgical ICU for surgical patients. When necessary, the surgical ICU houses critically ill medical patients requiring ongoing mechanical ventilation or respiratory care. Our open ICUs reside on the same floor of the hospital and their doors open onto the L-shaped corridor. This study was carried out over three periods of 6 months, from June 2011 to November 2012. Patients staying in the ICU for more than 48 h were included in the study. This study was approved by the institutional ethics committee. Intervention procedures This study included three periods. In our ICUs, patients were already receiving a daily bed bath by wiping with warm water and soap in a plastic basin, using multiple terry cloths, by the patients’ own nurses. This procedure was performed from June 2011 to November 2011 and was designated as the first period. The second period lasted from December 2011 to May 2012. During this period, patients received a weekly whole-body douche with warm water and soap. The third period was from June 2012 to November 2012. During this period, patients received a weekly whole-body douche with 2% CHG shower gel (Figure 1). The douche was performed with Dicideral 2% CHG shower gel (Bab Gencel Pharma Ghemical Ind. Co., Kırıkkale, Turkey) instead of soap. The patients were douched from the neck down with 4 oz of the CHG shower
Materials and methods Design overview and study objectives This study was a prospective intervention trial with a three-phase study. The objective of the study was to assess the efficacy of weekly CHG douche with regard to the incidence of HA-BSI in ICU patients in a tertiary-care hospital. The main study outcome was the rate of HA-BSIs, including CLABSI and laboratory-confirmed bloodstream infection (LCBSI). The secondary study outcome included the rate of other healthcare-associated infections (HAIs), i.e. ventilator-associated pneumonia (VAP), urinary tract infections (UTIs), and the number of multidrugresistant organisms isolated in the clinical cultures, i.e. methicillin-resistant Staphylococcus aureus (MRSA), vancomycin- resistant enterococci (VRE), and carbapenem-resistant Acinetobacter baumannii.
Figure 1. Implementing douche with chlorhexidine shower gel to a mechanically ventilated patient in the private bathroom.
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Effectiveness of weekly chlorhexidine douche gel. CHG exposure on face and ears was avoided as recommended by the manufacturer. These areas were cleaned with a nonmedicated washcloth, water, and soap. In all three periods patients were dried with nonsterile towels and their skins were moisturized with baby oil. Before the second and third periods, a private bathroom was constructed on the same corridor as the ICUs. A patient bedside monitoring system and a ventilator for mechanically ventilated patients were also established in this bathroom. Two HCWs were assigned to douche patients. These HCWs and ICU managers received education on the standardized douche procedures. Before whole-body douche, the patient’s catheter exit site was covered by a dressing with transparent film roll (3M Tegaderm Roll, 3M Health Care, USA) to avoid contact with water. Each patient’s body cleaning was performed via scrub with disposable nonmedicated washcloths using warm water and CHG shower gel. The shower gel with CHG was kept on the skin for 2 min during the cleaning of the hair and face, and then was rinsed. This procedure was applied weekly in this private bathroom by HCWs for each patient. On the other days, the patients’ faces were wiped daily with warm water and soap. But if a patient was contaminated with either stool or urine at any time, the contaminated areas were cleaned with soap and water, using nonmedicated washcloths. During the study periods, all ICU staffs were blinded to the study design. ICU managers observed douche procedures at least two times in a week and each patient was assessed by their own ICU manager immediately after the douche procedure for monitoring of skin reactions and cleaning quality. Infection control protocols and definitions The infection control procedures and guidelines on the prevention of nosocomial infections were followed according to the criteria of the Centers for Disease Control and Prevention (CDC) in our ICUs. Education and monitoring programs associated with infection control and prevention were continued during the three periods of the study. No other infection prevention interventions were introduced during the study. Patients were monitored daily for the development of nosocomial infection during their stay in the ICU and 72 h after discharge. All patients and clinical culture results were evaluated daily by the same infectious disease physician. Information about each patient, number of ICU admissions, and lengths of ICU stay were recorded on the nationwide surveillance system by the same infection control nurse. Decisions on infection and colonization were conducted according to clinical and laboratory evidence.
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HAIs were defined as recommended by the CDC [20]. We classified BSIs as CLABSIs and LCBSI. LCBSI was defined as a patient with a recognized pathogen cultured from one or more blood cultures and the organism was not related to an infection at another site; or a common skin contaminant (e.g. diphtheroids, Bacillus sp., Propionibacterium sp., coagulase-negative staphylococci or micrococci) was cultured from two or more blood cultures drawn on separate occasions and there were at least one of the following signs or symptoms: fever (⬎ 38°C), chills, or hypotension and signs and symptoms and positive laboratory results were not related to an infection at another site. CLABSI was defined as a patient with a central venous catheter meeting the above criteria. Insertion of a CVC in patients was conducted using a sterile technique, skin preparation with povidone-iodine, and maximum barrier precautions. CHG was not used for skin disinfection before CVC insertion and CVC care. Antibiotic-coated CVCs and chlorhexidine-impregnated CVC sponge dressings were not used in this study. The denominator for the CLABSI and LCBSI rates was 1000 CVC days and 1000 patient-days, respectively.
Statistical methods The sample size estimate was obtained from CLABSI and LCBSI rates of three ICUs 1 year before the initiation of the study. We had preliminary data suggesting 8.07% and 9.72% CLABSI and LCBSI rates, respectively. To achieve a statistically significant reduction in CLABSI and LCBSI rates with a power of 80%, we assumed that the BSI rates would decrease at least 30% from one period to another period. Poisson regression was used to assess the change in infection rates over time. Total infection counts were calculated using total CVC days, ventilator days, urinary catheter days, and patient days. Results were expressed as adjusted incidence rate ratios with accompanying 95% confidence intervals. All analyses were performed using SAS, version 9.2 (SAS Institute, Cary, NC, USA). p values ⬍ 0.05 were defined as statistically significant.
Results The ICU types, number of beds, number of patientdays, and number of admissions are shown in Table I; there were no significant changes during the periods of study. The LCBSI rates are presented in Table II. The CLABSI rates in the first, second, and third periods of study were 1.5, 1.2, and 1.4, respectively (p ⫽ 0.76). We did not observe a decrease in the rates
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D. Seyman et al. Table I. Characteristics of study units. No. of patient-days
ICU type
No. of admissions
No. of beds in ICU
First period
Second period
Third period
First period
Second period
Third period
12 9 12 33
1977 1591 1996 5564
2029 1590 2048 5667
1947 1550 2026 5523
386 319 386 1091
404 337 307 1048
515 288 403 1206
Surgical ICU Medical ICU Anesthesiology ICU Total ICU, intensive care unit.
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Table II. Comparison of laboratory-confirmed bloodstream infection rates during the three study periods. First period
Site Surgical ICU Medical ICU Anesthesiology ICU Total Adjusted ratee
No. of LCBSI Rated 16 11 11 38
8.09 6.91 5.51 8.4 7.1
Second period No. of LCBSI 7 8 15 30
Rate 3.45 5.03 7.32 6.1 4
First vs second perioda p value
Third period No. of LCBSI 10 8 3 21
0.03
Rate
Second vs third periodb p value
First vs third periodc p value
5.14 5.16 1.48 4 1.7
⬍ 0.001
⬍ 0.002
LCBSI, laboratory-confirmed bloodstream infection; first period, daily bed bath by wiping with water and soap; second period, weekly douche with water and soap; third period, weekly douche with chlorhexidine shower gel. aComparison of first and second period for LCBSI. bComparison of second and third period for LCBSI. cComparison of first and third period for LCBSI. dThe rates were defined as the number of LCBSIs per 1000 patient-days. eLCBSI rate was adjusted for total patient-days.
of CLABSI between periods. The LCBSI rates in the first, second, and third periods were 7.1, 4, and 1.7, respectively. The LCBSI rates were reduced 43.7% from the first period to the second period (relative risk (RR), 0.56; 95% confidence interval (CI), 0.33– 0.94; p ⫽ 0.03). In addition, there was a 57.5% reduction in LCBSI rates between the second and third period (RR, 0.44; 95% CI, 0.28–0.69; p ⬍ 0.001). Interestingly, the major decline (76.1%) was determined from the first to the third period (RR, 0.26; 95% CI, 0.06–0.96; p ⬍ 0.002). The distribution of pathogens isolated from LCBSIs during the study periods is presented in Table III. The most common gram-positive bacteria in LCBSI were enterococci. Not surprisingly, A. baumannii was the most common gram-negative bacterium. However, there was a significant decline in LCBSI rates from the first to the third period, the number of LCBSI due to carbapenem-resistant A. baumannii did not reduce from the first to the third period of the study (p ⫽ 0.28). Among the secondary outcomes, there was no significant difference in the VAP and UTI rates during the study periods (Table IV). The overall rates of
Table III. Pathogens isolated from patients with laboratoryconfirmed bloodstream infection during the three study periods. No. of isolates
Pathogens Gram-positive bacteria Coagulase-negative staphylococci Methicillin-sensitive Methicillin-resistant Staphylococcus aureus Methicillin-sensitive Methicillin-resistant Enterococcus spp. Vancomycin-sensitive Vancomycin-resistant Gram-negative bacteria Acinetobacter spp. Carbapenem-sensitive Carbapenem-resistant Klebsiella spp Pseudomonas spp. Escherichia coli Enterobacter spp. Proteus spp. Candida spp. Total
First period
Second period
Third period
10 3 0 3 2 0 2 5 4 1 20 14 6 8 4 1 1 0 0 8 38
12 4 2 2 0 0 0 8 7 1 16 7 1 6 5 0 2 1 1 3 31
5 4 3 1 1 0 1 0 0 0 10 6 1 5 3 1 0 0 0 5 20
Effectiveness of weekly chlorhexidine douche Table IV. Number of cases and infection rates of infection types in three study periods. First period
Second period
Third period
Type of infection
No. of cases
Rate
No. of cases
Rate
No. of cases
Rate
VAPa UTIb
8 9
0.71 0.87
23 21
3.12 2.75
26 17
3.34 1.88
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UTI, urinary tract infection; VAP, ventilator-associated pneumonia. aCases per 1000 ventilator-days. bCases per 1000 urinary catheter-days.
carbapenem-resistant A. baumannii, VRE, and MRSA infections in VAP, UTI, CLABSI, and LCBSI are shown in Table V. Because there were only small numbers of multidrug-resistant bacteria such as VRE and MRSA, statistical analysis could not be performed. Also the skin reactions among patients were not observed during the study periods.
Discussion In Turkey, a middle-income country, the infection prevention expenditures are paid out by hospitals, while the costs of HAIs are paid out by a health insurance company. Also, providing patient safety and reducing the HA-BSI rates are essential targets of the quality improvement indicator for hospital governance. In our ICUs, the targeted decline in CLABSI rates was not achieved despite implementation and establishment of a catheterization checklist and a catheter care bundle before the present study. This condition, in conjunction with the continued high mortality rate of patients and the high cost of HA-BSIs, has led to a quest for a novel prevention strategy on interventions to reduce HA-BSIs. It is well known that the most important step for the development of HA-BSI is skin colonization with hospital pathogens. Recently, the concept of whole-body bathing with an antiseptic solution such as CHG has been recommended to reduce
skin bacterial load. The association between the magnitude of the drop in HAI rates including CLABSI and daily CHG bathing was investigated by most studies carried out in the USA [10,12,15,21]. Generally, CHG-impregnated washcloths have been used in these studies. The CHG solution and CHG-impregnated cloths have equal effect on infection prevention [22]. However, CHG shower gel (US$ 0.4) is cheaper than CHG-impregnated cloth (US$3–US$4) for one patient bath. Both these procedures seem to produce additional financial burden in resource-limited settings but they are most likely cost-effective when compared with the estimated cost of managing a CLABSI (US$3700– US$29 000 per episode) [23–26]. We decided to perform patient douching with CHG to decrease HA-BSI rates in our ICUs. We would rather use a CHG shower gel because of the low cost. We used weekly CHG douche instead of daily CHG bathing. However, it was shown that the CHG concentration on the skin fell below effective levels after 1–3 days [27]. The main reason for administering weekly CHG bathing is the limited capacity of our ICU bathroom, in which the douche procedure was able to be performed a maximum of eight times a day. Earlier data have shown evidence of the effect of daily CHG bathing, such as decreases in skin colonization, cross-transmission, and bacteremia due to VRE and MRSA, infections caused by Clostridium difficile and blood culture contamination, and CLABSI rates [9,11–15,18,28]. Contrary to these observations, we did not find a potential beneficial effect on the CLABSI rate of weekly CHG douche in our study. Decolonization of the catheter exit site with CHG shower gel was not done, due to the suggestion of avoiding contact of the catheter with water by the manufacturer. The patients’ catheter exit site was covered with a transparent dressing during douche procedures. The undiminished CLABSI rates may be the result of dressing applications to skin surrounding the catheter exit site during douching.
Table V. Distribution of multidrug-resistant bacteria isolated from VAP, UTI, CLABSI, and LCBSI. First period
Clinical multidrug-resistant isolates CR Acinetobacter spp. MRSA VRE
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Second period
Third period
No. of cases
Rate
No. of cases
Rate
No. of cases
Rate
23 2 1
4.13 0.35 0.17
21 1 7
3.77 0.17 1.23
31 1 0
5.61 0.18 –
CLABSI, central line-associated bloodstream infection; CR, carbapenem resistant; LCBSI, laboratoryconfirmed bloodstream infection; MRSA; methicillin-resistant Staphylococcus aureus; UTI, urinary tract infection; VAP, ventilator-associated pneumonia; VRE; vancomycin-resistant enterococci. The rates were defined as cases per 1000 patient-days.
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We suggest that the decolonization of the catheter exit site should be performed with CHG instead of povidone-iodine after the douche procedure if the CHG shower gel is used for patients’ skin cleansing. Interestingly, we determined a significant decrease (43.7%) in the rates of LCBSI during the second period, compared with the first period. However, the most striking reduction (76.1%) in LCBSI was observed in the third period compared with the first period. We found one published study of weekly CHG bathing, resulting in a reduction of 33% in the rate of CLABSI compared with daily soap and water bathing, but it was done in a long-term acute care hospital. So our study is the first intervention trial to evaluate the effectiveness of weekly CHG douche in the ICU. In Turkey, there are no private HCWs responsible for patient care; it has been carried out routinely by nursing staff in the ICUs. The wiping technique was a time-consuming procedure. When the daily traditional basin bath was omitted during the second and third periods, the work burden of the nurses decreased markedly in the ICUs. In addition, all the ICU staff gave positive feedback that represented excellent patient cleaning during the second and third periods. When we introduced a private ICU bathroom and bathing team, including two HCWs, to eliminate variation in cleansing associated with nursing staff and increase the quality of the patient cleaning, we detected a reduction in the rate of LCBSI from the first to the second period. Unfortunately, we found only one study comparing types of bed bath, which compared the traditional basin bath with a prepackaged disposable bath, in terms of skin microbiology, time savings, patient’s comfort, and nurses’ satisfaction [29]. The latter study reported that differences in skin microbiology for the two types of baths were not clinically significant but the disposable bath was associated with taking less time and nurses’ satisfaction and higher costs. Consequently, we thought that the douche techniques reduced the skin microbial bioburden more than the traditional bath. The reduction in LCBSI rate during the second period is an indirect indicator of this comment. A limitation of our study is that a period with daily CHG douche was not included. The optimum implementation frequency for CHG bathing remains unclear due to lack of comparative studies involving different application intervals. Hereafter the implementation of this kind of studies needs to determine the minimally effective application interval for CHG bathing. Recently a slight increase in the median CHG minimum inhibitory concentration (MIC) level of cultivable cutaneous bacteria, especially staphylococci, has been reported despite significant decreases in bacterial colony counts [30]. Similar reduced
susceptibility to CHG among gram-negative bacteria, particularly Pseudomonas spp. and Klebsiella spp., has been determined [31,32]. The observed increase in the median CHG MIC level is closely correlated with increased use of CHG. The elevated CHG MICs may result from reduced susceptibility to the antiseptic and other antimicrobials [10,29]. This situation is a serious threat for the future and calls for a reassessment of the timing of CHG bathing. Therefore CHG susceptibility testing should be performed at regular intervals for monitoring of CHG resistance or loss of clinical effectiveness. In conclusion, the decline of HAIs allows for savings in resources, finances, and staff time. A weekly CHG douche procedure can help these targets. According to our knowledge, a study evaluating the effectiveness of CHG bathing periods has not been described in the ICU, until now. Further studies are needed to validate the clinical impact of different intervals for CHG bathing. The present study is the first trial to evaluate the effectiveness of weekly CHG douche in the ICU.
Acknowledgments The authors would like to thank the hospital administrators for providing the private bathroom. Declaration of interest: The authors report no conflicts of interest related to this study. The authors alone are responsible for the content and writing of the paper.
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ORIGINAL ARTICLE
Weekly chlorhexidine douche: does it reduce healthcare-associated bloodstream infections?
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DERYA SEYMAN1, NEFISE OZTOPRAK1, HANDE BERK1, FILIZ KIZILATES1 & MESTAN EMEK2 1Antalya
Education and Research Hospital, Department of Infectious Diseases and Clinical Microbiology and 2Public Health Institution, Department of Public Health and Epidemiology, Antalya, Turkey
Abstract Background: Daily chlorhexidine (CHG) bathing has been used as a precaution to reduce the rate of healthcare-associated bloodstream infections (HA-BSI). The application frequency of CHG bathing remains unclear, this procedure has been implemented daily by this time. The aim of this study was to determine the efficacy of weekly whole-body douche with CHG shower gel on rates of HA-BSI. Methods: We conducted a prospective intervention trial in medical, surgical, and anesthesiology intensive care units (ICUs) in a tertiary teaching hospital from June 2011 to November 2012. This study included three periods. During the first period, patients received a daily bed bath by wiping with water and soap. In the second period patients were given a weekly douche with water and soap; in the third period patients were given a weekly douche with CHG shower gel. The rates of HA-BSI were compared between the three periods using Poisson regression analysis. Results: The central line-associated bloodstream infection rates did not decline significantly between periods (p ⫽ 0.76). The laboratory-confirmed bloodstream infection (LCBSI) rates in the first, second, and third periods were 7.1, 4, and 1.7, respectively. The LCBSI rates were reduced 43.7% from the first period to the second period (p ⫽ 0.03). In addition, there was a 57.5% reduction in LCBSI rates between the second and third periods (p ⬍ 0.001). Interestingly, the major decline (76.1%) was determined from the first to the third period (p ⬍ 0.002). Conclusions: Weekly douche with CHG shower gel significantly reduced LCBSI rates. Further studies are needed to validate the clinical impact of different intervals of CHG bathing.
Keywords: Weekly douche, chlorhexidine shower gel, bloodstream infection
Introduction Healthcare-associated bloodstream infections (HABSIs) are a serious problem among the critically ill patients admitted to intensive care units (ICUs), which are often associated with higher morbidity and mortality rates and increased lengths of stay, as well as additional medical cost of care in this population [1]. These infections are a serious threat to patient safety in the ICUs. It is believed that most episodes of HA-BSI are preventable. The majority of these infections are associated with the use of a central venous catheter (CVC) and are called central lineassociated bloodstream infections (CLABSIs). The risks of developing HA-BSI depend on certain factors such as type of ICU, appropriate hospital infrastructure, quality of patient care, and practical implementation of preventive steps to reduce CLABSI.
The prevention of HA-BSI is a vital component in the management of critically ill patients. Several approaches for the prevention of HA-BSI have been proposed, including the use of central line care bundles, specific practical measures such as hand hygiene in healthcare workers (HCWs), maximal barrier precautions for catheter insertion (use of cap, mask, sterile gloves, full sleeved sterile gown, and large sterile drapes), and preferential use of the subclavian site for CVC insertion [2,3]. Different studies conducted on these topics have reported improvement in the rates of HA-BSI, especially CLABSI. However, a limited number of studies have recorded near-zero rates for CLABSI [4–7]. Furthermore, the economic burden of these infections is high and a reduction in these rates would be advantageous for healthcare facilities [8]. In particular, in Turkey, the
Correspondence: Derya Seyman MD Specialist, Antalya Eg˘itim ve Aras¸tırma Hastanesi, Enfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Klinig˘i, 07100 Antalya, Turkey. Tel: ⫹ 90 242 249 34 25. Fax: ⫹ 90 242 249 44 62. E-mail: [email protected] (Received 16 April 2014 ; accepted 30 May 2014 ) ISSN 0036-5548 print/ISSN 1651-1980 online © 2014 Informa Healthcare DOI: 10.3109/00365548.2014.931597
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rates of HA-BSI are indicators of a hospital’s quality performance criteria. The bacterial colonization of the skin plays a large role in the pathogenesis of HA-BSI. The portal of bacterial entry into the bloodstream is probably from impairments in skin entirety caused by invasive devices [2]. Therefore, some authors have suggested a new approach targeting universal decolonization strategies such as daily bathing with chlorhexidine gluconate (CHG) to reduce skin microbial bioburden [9]. It has been shown that the use of CHG bathing is associated with a significant decrease in HA-BSI rates, especially CLABSI, and in skin colonization with multidrug-resistant organisms in adult ICU patients [10–15]. Based on these observations, CHG bathing is a reasonable approach for decolonization of the whole body in routine daily ICU patient care skills. CHG is a potent antiseptic agent in widespread use in medical care. It is used in preoperative skin cleansing preparations, hand disinfectants, oral mouth rinses, and skin antiseptic, as it is efficacious against gram-positive and -negative bacteria [16]. There are various kinds of products with CHG in clinical practice, such as solution, soap or gels and washcloths impregnated or saturated with CHG [17]. Most of the studies performed in ICUs include using a daily CHG bathing system with CHGimpregnated washcloths without rinsing. In the literature, there are few studies using CHG solution and only one study evaluating the effect of weekly CHG bathing, which was performed at a long-term acute care hospital [12,18,19]. In the present study, we assessed the influence of a weekly douche with CHG shower gel on the rate of HA-BSI in ICUs.
Setting and patients Antalya Education and Research Hospital is a 1000bed, tertiary teaching hospital with about 67 921 admissions annually in Antalya, Turkey. The hospital has a 12-bed adult ICU run by the Anaesthesiology Department, a 9-bed medical ICU for medical patients, and a 12-bed surgical ICU for surgical patients. When necessary, the surgical ICU houses critically ill medical patients requiring ongoing mechanical ventilation or respiratory care. Our open ICUs reside on the same floor of the hospital and their doors open onto the L-shaped corridor. This study was carried out over three periods of 6 months, from June 2011 to November 2012. Patients staying in the ICU for more than 48 h were included in the study. This study was approved by the institutional ethics committee. Intervention procedures This study included three periods. In our ICUs, patients were already receiving a daily bed bath by wiping with warm water and soap in a plastic basin, using multiple terry cloths, by the patients’ own nurses. This procedure was performed from June 2011 to November 2011 and was designated as the first period. The second period lasted from December 2011 to May 2012. During this period, patients received a weekly whole-body douche with warm water and soap. The third period was from June 2012 to November 2012. During this period, patients received a weekly whole-body douche with 2% CHG shower gel (Figure 1). The douche was performed with Dicideral 2% CHG shower gel (Bab Gencel Pharma Ghemical Ind. Co., Kırıkkale, Turkey) instead of soap. The patients were douched from the neck down with 4 oz of the CHG shower
Materials and methods Design overview and study objectives This study was a prospective intervention trial with a three-phase study. The objective of the study was to assess the efficacy of weekly CHG douche with regard to the incidence of HA-BSI in ICU patients in a tertiary-care hospital. The main study outcome was the rate of HA-BSIs, including CLABSI and laboratory-confirmed bloodstream infection (LCBSI). The secondary study outcome included the rate of other healthcare-associated infections (HAIs), i.e. ventilator-associated pneumonia (VAP), urinary tract infections (UTIs), and the number of multidrugresistant organisms isolated in the clinical cultures, i.e. methicillin-resistant Staphylococcus aureus (MRSA), vancomycin- resistant enterococci (VRE), and carbapenem-resistant Acinetobacter baumannii.
Figure 1. Implementing douche with chlorhexidine shower gel to a mechanically ventilated patient in the private bathroom.
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Effectiveness of weekly chlorhexidine douche gel. CHG exposure on face and ears was avoided as recommended by the manufacturer. These areas were cleaned with a nonmedicated washcloth, water, and soap. In all three periods patients were dried with nonsterile towels and their skins were moisturized with baby oil. Before the second and third periods, a private bathroom was constructed on the same corridor as the ICUs. A patient bedside monitoring system and a ventilator for mechanically ventilated patients were also established in this bathroom. Two HCWs were assigned to douche patients. These HCWs and ICU managers received education on the standardized douche procedures. Before whole-body douche, the patient’s catheter exit site was covered by a dressing with transparent film roll (3M Tegaderm Roll, 3M Health Care, USA) to avoid contact with water. Each patient’s body cleaning was performed via scrub with disposable nonmedicated washcloths using warm water and CHG shower gel. The shower gel with CHG was kept on the skin for 2 min during the cleaning of the hair and face, and then was rinsed. This procedure was applied weekly in this private bathroom by HCWs for each patient. On the other days, the patients’ faces were wiped daily with warm water and soap. But if a patient was contaminated with either stool or urine at any time, the contaminated areas were cleaned with soap and water, using nonmedicated washcloths. During the study periods, all ICU staffs were blinded to the study design. ICU managers observed douche procedures at least two times in a week and each patient was assessed by their own ICU manager immediately after the douche procedure for monitoring of skin reactions and cleaning quality. Infection control protocols and definitions The infection control procedures and guidelines on the prevention of nosocomial infections were followed according to the criteria of the Centers for Disease Control and Prevention (CDC) in our ICUs. Education and monitoring programs associated with infection control and prevention were continued during the three periods of the study. No other infection prevention interventions were introduced during the study. Patients were monitored daily for the development of nosocomial infection during their stay in the ICU and 72 h after discharge. All patients and clinical culture results were evaluated daily by the same infectious disease physician. Information about each patient, number of ICU admissions, and lengths of ICU stay were recorded on the nationwide surveillance system by the same infection control nurse. Decisions on infection and colonization were conducted according to clinical and laboratory evidence.
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HAIs were defined as recommended by the CDC [20]. We classified BSIs as CLABSIs and LCBSI. LCBSI was defined as a patient with a recognized pathogen cultured from one or more blood cultures and the organism was not related to an infection at another site; or a common skin contaminant (e.g. diphtheroids, Bacillus sp., Propionibacterium sp., coagulase-negative staphylococci or micrococci) was cultured from two or more blood cultures drawn on separate occasions and there were at least one of the following signs or symptoms: fever (⬎ 38°C), chills, or hypotension and signs and symptoms and positive laboratory results were not related to an infection at another site. CLABSI was defined as a patient with a central venous catheter meeting the above criteria. Insertion of a CVC in patients was conducted using a sterile technique, skin preparation with povidone-iodine, and maximum barrier precautions. CHG was not used for skin disinfection before CVC insertion and CVC care. Antibiotic-coated CVCs and chlorhexidine-impregnated CVC sponge dressings were not used in this study. The denominator for the CLABSI and LCBSI rates was 1000 CVC days and 1000 patient-days, respectively.
Statistical methods The sample size estimate was obtained from CLABSI and LCBSI rates of three ICUs 1 year before the initiation of the study. We had preliminary data suggesting 8.07% and 9.72% CLABSI and LCBSI rates, respectively. To achieve a statistically significant reduction in CLABSI and LCBSI rates with a power of 80%, we assumed that the BSI rates would decrease at least 30% from one period to another period. Poisson regression was used to assess the change in infection rates over time. Total infection counts were calculated using total CVC days, ventilator days, urinary catheter days, and patient days. Results were expressed as adjusted incidence rate ratios with accompanying 95% confidence intervals. All analyses were performed using SAS, version 9.2 (SAS Institute, Cary, NC, USA). p values ⬍ 0.05 were defined as statistically significant.
Results The ICU types, number of beds, number of patientdays, and number of admissions are shown in Table I; there were no significant changes during the periods of study. The LCBSI rates are presented in Table II. The CLABSI rates in the first, second, and third periods of study were 1.5, 1.2, and 1.4, respectively (p ⫽ 0.76). We did not observe a decrease in the rates
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D. Seyman et al. Table I. Characteristics of study units. No. of patient-days
ICU type
No. of admissions
No. of beds in ICU
First period
Second period
Third period
First period
Second period
Third period
12 9 12 33
1977 1591 1996 5564
2029 1590 2048 5667
1947 1550 2026 5523
386 319 386 1091
404 337 307 1048
515 288 403 1206
Surgical ICU Medical ICU Anesthesiology ICU Total ICU, intensive care unit.
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Table II. Comparison of laboratory-confirmed bloodstream infection rates during the three study periods. First period
Site Surgical ICU Medical ICU Anesthesiology ICU Total Adjusted ratee
No. of LCBSI Rated 16 11 11 38
8.09 6.91 5.51 8.4 7.1
Second period No. of LCBSI 7 8 15 30
Rate 3.45 5.03 7.32 6.1 4
First vs second perioda p value
Third period No. of LCBSI 10 8 3 21
0.03
Rate
Second vs third periodb p value
First vs third periodc p value
5.14 5.16 1.48 4 1.7
⬍ 0.001
⬍ 0.002
LCBSI, laboratory-confirmed bloodstream infection; first period, daily bed bath by wiping with water and soap; second period, weekly douche with water and soap; third period, weekly douche with chlorhexidine shower gel. aComparison of first and second period for LCBSI. bComparison of second and third period for LCBSI. cComparison of first and third period for LCBSI. dThe rates were defined as the number of LCBSIs per 1000 patient-days. eLCBSI rate was adjusted for total patient-days.
of CLABSI between periods. The LCBSI rates in the first, second, and third periods were 7.1, 4, and 1.7, respectively. The LCBSI rates were reduced 43.7% from the first period to the second period (relative risk (RR), 0.56; 95% confidence interval (CI), 0.33– 0.94; p ⫽ 0.03). In addition, there was a 57.5% reduction in LCBSI rates between the second and third period (RR, 0.44; 95% CI, 0.28–0.69; p ⬍ 0.001). Interestingly, the major decline (76.1%) was determined from the first to the third period (RR, 0.26; 95% CI, 0.06–0.96; p ⬍ 0.002). The distribution of pathogens isolated from LCBSIs during the study periods is presented in Table III. The most common gram-positive bacteria in LCBSI were enterococci. Not surprisingly, A. baumannii was the most common gram-negative bacterium. However, there was a significant decline in LCBSI rates from the first to the third period, the number of LCBSI due to carbapenem-resistant A. baumannii did not reduce from the first to the third period of the study (p ⫽ 0.28). Among the secondary outcomes, there was no significant difference in the VAP and UTI rates during the study periods (Table IV). The overall rates of
Table III. Pathogens isolated from patients with laboratoryconfirmed bloodstream infection during the three study periods. No. of isolates
Pathogens Gram-positive bacteria Coagulase-negative staphylococci Methicillin-sensitive Methicillin-resistant Staphylococcus aureus Methicillin-sensitive Methicillin-resistant Enterococcus spp. Vancomycin-sensitive Vancomycin-resistant Gram-negative bacteria Acinetobacter spp. Carbapenem-sensitive Carbapenem-resistant Klebsiella spp Pseudomonas spp. Escherichia coli Enterobacter spp. Proteus spp. Candida spp. Total
First period
Second period
Third period
10 3 0 3 2 0 2 5 4 1 20 14 6 8 4 1 1 0 0 8 38
12 4 2 2 0 0 0 8 7 1 16 7 1 6 5 0 2 1 1 3 31
5 4 3 1 1 0 1 0 0 0 10 6 1 5 3 1 0 0 0 5 20
Effectiveness of weekly chlorhexidine douche Table IV. Number of cases and infection rates of infection types in three study periods. First period
Second period
Third period
Type of infection
No. of cases
Rate
No. of cases
Rate
No. of cases
Rate
VAPa UTIb
8 9
0.71 0.87
23 21
3.12 2.75
26 17
3.34 1.88
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UTI, urinary tract infection; VAP, ventilator-associated pneumonia. aCases per 1000 ventilator-days. bCases per 1000 urinary catheter-days.
carbapenem-resistant A. baumannii, VRE, and MRSA infections in VAP, UTI, CLABSI, and LCBSI are shown in Table V. Because there were only small numbers of multidrug-resistant bacteria such as VRE and MRSA, statistical analysis could not be performed. Also the skin reactions among patients were not observed during the study periods.
Discussion In Turkey, a middle-income country, the infection prevention expenditures are paid out by hospitals, while the costs of HAIs are paid out by a health insurance company. Also, providing patient safety and reducing the HA-BSI rates are essential targets of the quality improvement indicator for hospital governance. In our ICUs, the targeted decline in CLABSI rates was not achieved despite implementation and establishment of a catheterization checklist and a catheter care bundle before the present study. This condition, in conjunction with the continued high mortality rate of patients and the high cost of HA-BSIs, has led to a quest for a novel prevention strategy on interventions to reduce HA-BSIs. It is well known that the most important step for the development of HA-BSI is skin colonization with hospital pathogens. Recently, the concept of whole-body bathing with an antiseptic solution such as CHG has been recommended to reduce
skin bacterial load. The association between the magnitude of the drop in HAI rates including CLABSI and daily CHG bathing was investigated by most studies carried out in the USA [10,12,15,21]. Generally, CHG-impregnated washcloths have been used in these studies. The CHG solution and CHG-impregnated cloths have equal effect on infection prevention [22]. However, CHG shower gel (US$ 0.4) is cheaper than CHG-impregnated cloth (US$3–US$4) for one patient bath. Both these procedures seem to produce additional financial burden in resource-limited settings but they are most likely cost-effective when compared with the estimated cost of managing a CLABSI (US$3700– US$29 000 per episode) [23–26]. We decided to perform patient douching with CHG to decrease HA-BSI rates in our ICUs. We would rather use a CHG shower gel because of the low cost. We used weekly CHG douche instead of daily CHG bathing. However, it was shown that the CHG concentration on the skin fell below effective levels after 1–3 days [27]. The main reason for administering weekly CHG bathing is the limited capacity of our ICU bathroom, in which the douche procedure was able to be performed a maximum of eight times a day. Earlier data have shown evidence of the effect of daily CHG bathing, such as decreases in skin colonization, cross-transmission, and bacteremia due to VRE and MRSA, infections caused by Clostridium difficile and blood culture contamination, and CLABSI rates [9,11–15,18,28]. Contrary to these observations, we did not find a potential beneficial effect on the CLABSI rate of weekly CHG douche in our study. Decolonization of the catheter exit site with CHG shower gel was not done, due to the suggestion of avoiding contact of the catheter with water by the manufacturer. The patients’ catheter exit site was covered with a transparent dressing during douche procedures. The undiminished CLABSI rates may be the result of dressing applications to skin surrounding the catheter exit site during douching.
Table V. Distribution of multidrug-resistant bacteria isolated from VAP, UTI, CLABSI, and LCBSI. First period
Clinical multidrug-resistant isolates CR Acinetobacter spp. MRSA VRE
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Second period
Third period
No. of cases
Rate
No. of cases
Rate
No. of cases
Rate
23 2 1
4.13 0.35 0.17
21 1 7
3.77 0.17 1.23
31 1 0
5.61 0.18 –
CLABSI, central line-associated bloodstream infection; CR, carbapenem resistant; LCBSI, laboratoryconfirmed bloodstream infection; MRSA; methicillin-resistant Staphylococcus aureus; UTI, urinary tract infection; VAP, ventilator-associated pneumonia; VRE; vancomycin-resistant enterococci. The rates were defined as cases per 1000 patient-days.
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We suggest that the decolonization of the catheter exit site should be performed with CHG instead of povidone-iodine after the douche procedure if the CHG shower gel is used for patients’ skin cleansing. Interestingly, we determined a significant decrease (43.7%) in the rates of LCBSI during the second period, compared with the first period. However, the most striking reduction (76.1%) in LCBSI was observed in the third period compared with the first period. We found one published study of weekly CHG bathing, resulting in a reduction of 33% in the rate of CLABSI compared with daily soap and water bathing, but it was done in a long-term acute care hospital. So our study is the first intervention trial to evaluate the effectiveness of weekly CHG douche in the ICU. In Turkey, there are no private HCWs responsible for patient care; it has been carried out routinely by nursing staff in the ICUs. The wiping technique was a time-consuming procedure. When the daily traditional basin bath was omitted during the second and third periods, the work burden of the nurses decreased markedly in the ICUs. In addition, all the ICU staff gave positive feedback that represented excellent patient cleaning during the second and third periods. When we introduced a private ICU bathroom and bathing team, including two HCWs, to eliminate variation in cleansing associated with nursing staff and increase the quality of the patient cleaning, we detected a reduction in the rate of LCBSI from the first to the second period. Unfortunately, we found only one study comparing types of bed bath, which compared the traditional basin bath with a prepackaged disposable bath, in terms of skin microbiology, time savings, patient’s comfort, and nurses’ satisfaction [29]. The latter study reported that differences in skin microbiology for the two types of baths were not clinically significant but the disposable bath was associated with taking less time and nurses’ satisfaction and higher costs. Consequently, we thought that the douche techniques reduced the skin microbial bioburden more than the traditional bath. The reduction in LCBSI rate during the second period is an indirect indicator of this comment. A limitation of our study is that a period with daily CHG douche was not included. The optimum implementation frequency for CHG bathing remains unclear due to lack of comparative studies involving different application intervals. Hereafter the implementation of this kind of studies needs to determine the minimally effective application interval for CHG bathing. Recently a slight increase in the median CHG minimum inhibitory concentration (MIC) level of cultivable cutaneous bacteria, especially staphylococci, has been reported despite significant decreases in bacterial colony counts [30]. Similar reduced
susceptibility to CHG among gram-negative bacteria, particularly Pseudomonas spp. and Klebsiella spp., has been determined [31,32]. The observed increase in the median CHG MIC level is closely correlated with increased use of CHG. The elevated CHG MICs may result from reduced susceptibility to the antiseptic and other antimicrobials [10,29]. This situation is a serious threat for the future and calls for a reassessment of the timing of CHG bathing. Therefore CHG susceptibility testing should be performed at regular intervals for monitoring of CHG resistance or loss of clinical effectiveness. In conclusion, the decline of HAIs allows for savings in resources, finances, and staff time. A weekly CHG douche procedure can help these targets. According to our knowledge, a study evaluating the effectiveness of CHG bathing periods has not been described in the ICU, until now. Further studies are needed to validate the clinical impact of different intervals for CHG bathing. The present study is the first trial to evaluate the effectiveness of weekly CHG douche in the ICU.
Acknowledgments The authors would like to thank the hospital administrators for providing the private bathroom. Declaration of interest: The authors report no conflicts of interest related to this study. The authors alone are responsible for the content and writing of the paper.
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