Urinary tract infections (UTIs) represented ∼15%–20% of all healthcare-associated infections, and ∼60% of these are associated with urinary catheters, which are used in up to 16% of inpatients. 1 Up to 70% of UTIs are avoidable with the use of evidence-based prevention practices. Reference Umscheid, Mitchell, Doshi, Agarwal, Williams and Brennan2
Personal hygiene, including bathing, is a nursing activity related to quality of life and of medical care. The most widespread, well-described technique is conventional hygiene, which consists of washing the patient with a sponge or cloth, soap, and water from a basin. Over the last decade, waterless hygiene with the use of presaturated clothes has emerged as an alternative to conventional regimens. Reference Groven, Zwakhalen, Odekerken-Schröder, Joosten and Hamers3
Some researchers maintain that hygiene with water can increase the risk of nosocomial infection because the mechanical friction causes the shedding of cells containing microorganisms, which leads to contamination of the water. Similarly, tap water, toilets, sinks, and basins can act as a reservoir for microorganisms that cause nosocomial infections. Reference Anaissie, Penzak and Dignani4,Reference Shaw, Gavaldà and Càmara5
Given the importance of preventing UTIs and the scarcity of studies related to patient hygiene, we assessed hygiene with presaturated wipes versus conventional hygiene in cardiac-surgery, bedridden patients for reducing catheter-associated urinary tract infections (CAUTIs).
Methods
This open-label, randomized controlled trial took place in the Germans Trias i Pujol University Hospital between January 2019 and February 2020. We followed the CONSORT reporting guidelines for studies of nonpharmacological interventions. Reference Barbour, Bhui and Chescheir6
Participants
Patients undergoing cardiac surgery who were bedridden, had an indwelling urinary catheter, and provided signed informed consent were eligible to participate in the study. Exclusion criteria included the following: missing records, patients admitted from other units with urinary catheters, patients with previous UTI in last 3 months, and language barrier. Patients were consecutively recruited until the sample size was reached. Upon enrollment, participants were randomized to parallel groups (1:1) using a random numbers table. Patients were withdrawn from the study if they demonstrated hypersensitivity to any component of the hygiene protocol, were transferred to other services, voluntarily dropped out, or died before completing the follow-up.
Intervention
The control group received conventional patient hygiene with water and soap, and the experimental group received dry hygiene with wipes impregnated with soap and moisturizing lotion containing polyhexanide (Prontoderm wipes, B. Braun, Melsungen, Germany). Nursing professionals in the participating services received training on the hygiene protocol designed for the study. Urine samples were collected following hospital protocol and only in patients with clinically suspected infection.
Ethical considerations
The hospital’s clinical ethics committee approved the study (code PI-18-173), and participants were asked to sign informed consent forms. Infection control nursing staff collected the data using a questionnaire regarding the study variables.
Study variables
The primary outcome was the occurrence of a CAUTI as defined by the Centers for Disease Control and Prevention. Reference Horan, Andrus and Dudeck7
Other variables included age, sex, comorbidity according to the Charlson comorbidity index, days of catheterization, skin integrity, microorganism in urine culture, antibiotic administration, treatment duration, and discharge outcome.
Statistical analysis
Assuming an α (alpha) risk of 5% and allowing a 5% dropout rate, to provide 80% power, 100 individuals were required in each group.
The accumulated incidence of CAUTI was calculated with 95% confidence intervals (CIs), and groups were compared in univariable analyses using the χ2 test or the Fisher exact test or the Student t test or the Mann-Whitney U test. The study arm (experimental or control) was introduced into a multivariable logistic regression model adjusted for sex and days of catheterization. All analyses were performed using SPSS version 24 statistical software (IBM, Armonk, NY). Two-tailed P values < .05 were considered significant.
Results
In total, 212 patients were included in the study, of whom 170 (85 per arm) were included in the analysis (Fig. 1). The only significant difference between groups was comorbidity: the Charlson index was higher in the control group (P = .008).
Figure 1. Participant Flow.
The duration of catheterization ranged from 1 to 35 days. CAUTI was significantly more frequent in the control group [n = 14 (16.5%; 95% CI, 9.7%–25.5%) vs n = 5 (5.9%; 95% CI, 2.2%–12.5%); P = .035]. The incidence of CAUTI was higher among female participants (25.0%; 95% CI, 13.9%–39.3%) than male participants (6.4%; 95% CI, 3.1%–11.8%; P = .002).
In the multivariable analysis (Table 1), CAUTI was independently associated with conventional hygiene (odds ratio [OR], 4.1; 95% CI, 1.3–12.7). In the 19 patients with CAUTI, 12 (60%) had infections caused by Enterobacteriaceae (n = 9 controls vs n = 3 experimental). Pseudomonas spp were isolated in 3 cases, all in the control group. Also, 4 patients (20%) presented with polymicrobial cultures (75% in the control group). In addition, 19 patients (95%) received antibiotics during their hospital stay, and 58% of these continued this treatment after discharge.
Table 1. Factors Associated With Catheter-Associated Urinary Tract Infection (CAUTI), Univariable and Multivariate Analysis
Note. UTI, urinary tract infection; CI, confidence interval; OR, odds ratio; SD, standard deviation.
Most patients (94.1%) maintained skin integrity. More patients receiving conventional (7.1%) versus dry hygiene (3.5%) developed moisture-induced skin lesions, but the difference was not significant.
Regarding the discharge outcome, 89.1% of participants were discharged home and 4.1% died from noninfectious causes.
Discussion
Our study provides evidence from an open-label, randomized controlled trial that water-based hygiene in bedridden patients with a urinary catheter is associated with a higher risk of CAUTI than hygiene with presaturated wipes.
A systematic review showed that waterless hygiene reduces the incidence of urinary infection Reference Strouse8 and recommended that healthcare centers consider eliminating patient bathing with basins. Other researchers Reference Reagan, Chan and Vanhoozer9 found a reduction in UTIs when dry bathing practices were implemented, although most evidence is from before-and-after studies comparing wet wipes impregnated with chlorhexidine to traditional soap, so the reduction could be due to the incorporation of the antiseptic.
In contrast, other researchers Reference Boonyasiri, Thaisiam and Permpikul10 found insufficient evidence for the clinical efficacy of wet wipes with chlorhexidine and suggested the need for randomized clinical trials.
In our study, CAUTI was independently associated with conventional water-based hygiene.
Most of the patients with CAUTI (60%) had an enterobacterial infection. The polymicrobial cultures, which were more frequent in the water-based hygiene arm, could reflect an excess of periurethral ascending contamination during washing with soap and water.
Groven et al Reference Groven, Zwakhalen, Odekerken-Schröder, Joosten and Hamers3 found that dry washing was associated with fewer skin lesions than conventional hygiene. We also observed that more patients receiving conventional versus dry hygiene developed skin lesions, although we failed to detect a statistically significant difference. One of the strengths of the current study was the inclusion of a randomly assigned control group and the incorporation of the change in hygiene technique with wet wipes as an isolated measure, rather than part of a multicomponent intervention.
This study had several limitations. The study was not double-blinded due to the type of intervention. Also, patients lost to follow-up in both study arms, which may have led to bias due to the lack of information on these patients. Also, the study was limited to cardiac surgery patients; thus, these results may not be generalizable to other populations.
In conclusion, in bedridden patients with a urinary catheter, the use of presaturated wipes significantly reduced the incidence of CAUTI compared to conventional soap-and-water hygiene. Despite not containing an antiseptic, the wipes used in our study reduced the incidence of CAUTI without disruption of skin integrity. Thus, performing skin hygiene presaturated wipes is a safe alternative to soap and water.
Acknowledgements
We acknowledge the contributions of Ms. Àngels Barberà, A. Bayés, and P. Ricart, and of all the nurses and physicians of the Cardiac Surgery and Intensive Care medical services at the Germans Trias i Pujol University Hospital. The company B. Braun Medical donated the sanitary product after both parties had signed an agreement of no commitment.
Financial support
This work was supported by the “Trias Talents” Program of the Germans Trias i Pujol Research Institute and University Hospital.
Conflicts of interest
All authors report no conflicts of interest relevant to this article.
