The use of high-cost antiseptic washcloths on ICU patients results in no statistically significant difference in rates of infection for four hospital-acquired infections, researchers find.
Bathing hospital ICU patients daily with disposable washcloths containing chlorhexidine gluconate (CHG), doesn't prevent four types of hospital-acquired infections any more than bathing patients without the antimicrobial cloths, researchers say.
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Michael Noto, MD |
That's the controversial conclusion from a study published in the current issue of JAMA evaluating the product's use in 10,000 patients treated at Vanderbilt University Medical Center during a 12-month period ending in July, 2013.
CHG is an antimicrobial that can cost large hospitals hundreds of thousands of dollars a year. "If a hospital is talking about spending $200,000, $500,000 or $700,000 a year on this treatment, our study should give them pause to reconsider that decision," says Arthur Wheeler, MD, a Vanderbilt professor of pulmonary care medicine and critical care and the study's senior author.
"That's because when you apply this practice broadly to an entire hospital's ICU patients, our data suggest that you're not going to reduce the incidence of hospital-acquired infections."
In the study led by Vanderbilt infectious disease researcher Michael Noto, MD, ICU patients at VUMC's five adult ICUs with a total of 160 beds were split into two groups. In one, patients were washed with 2% CHG washcloths sold by Sage Products. In the other, patients were washed with disposable non-antimicrobial cloths made by either Comfort Bath or Sage Products. The study's crossover design eliminated the possibility that a practice in a particular ICU might influence the result.
The data revealed no statistically significant difference in central line bloodstream (CLABSI), catheter-associated urinary tract (CAUTI), ventilator-associated pneumonia (VAP) or Clostridium difficile infections.
ICU Infection Prevention Practices Lax
Wheeler cautions that at baseline, Vanderbilt did not have high rates of those infections, so for a hospital with significantly more infections, CHG bathing might make more sense. But for hospitals with low rates, using CHG wipes "is like carrying an umbrella every day in a town where it rains only once or twice every 20,000 days. Maybe there'd be one day when the umbrella would protect you from the rain."
Study 'Definitely Gives Pause'
Use of CHG products is not without an occasional adverse event. They can cause rashes, prompt allergic reactions in some patients, and may encourage the emergence of chlorhexidine-resistant organisms.
Reached for comment by e-mail, Derek Angus, MD, of the Department of Critical Care Medicine at the University of Pittsburgh, co-author of an editorial about the Vanderbilt study in the same issue of JAMA, said that around the country, many hospitals have been adopting daily CHG bathing as a protocol in recent years. For those that have or are thinking of doing it, he wrote, "this study definitely gives pause."
Angus says that CHG "does cause rash and allergies in a very small proportion of patients, and though it is generally benign, it is not free of problems, and those who are allergic will be pretty miserable."
Wheeler says he knows the study will generate controversy because its results are markedly different from a similar study published in the New England Journal of Medicine in 2013. That study did find that daily use of CHG-impregnated washcloths reduced rates of multi-drug resistant organisms in ICUs and bone transplant units.
Nurses' Unlikely Infection Control Tool Quashes HAI
At a recent conference, he and his colleagues received a number of adversarial comments. "People are saying, 'why don't you want to prevent infections?' But it's not that we don't want to prevent infections, it's just that the data we have says chlorhexidine doesn't work."
"Also, if you are an infection control doctor and your entire raison d'etre is to prevent infections, even a study at a large medical center like Vanderbilt, with 10,000 patients, is not going to dissuade you."
Walker says that hospital leaders should see this as an opportunity to reroute spending to more effective infection control strategies, such as handwashing. "Now you have $350,000 or so to spend on something else that might work," he says.
Not So Fast
But Dan Diekema, MD, Director, Division of Infectious Diseases at the University of Iowa who helps run the Controversies in Hospital Infection Prevention blog, says the study "may change practice in some centers—it's impossible to predict—but in my view, it should not change current practice or recommendations."
He says the study "is not definitive. It is a single-center effectiveness study and adherence to the CHG bathing was not monitored, both of which impact the generalizability."
"More importantly, the composite endpoint they chose includes infections for which there is no good evidence, and very little biological plausibility, to suggest that CHG bathing should be effective [against] CAUTI, VAP, and C. diff," Diekema says.
The Vanderbilt data also appears to be at odds with guidelines issued last year by the Society for Healthcare Epidemiology of America (SHEA) for prevention of CLABSI. Those guidelines score CHG as having the highest "quality of evidence," and urge providers to "bathe ICU patients over two months of age with a chlorhexidine preparation on a daily basis."
SHEA President Anthony Harris, MD, epidemiologist at the University of Maryland Medical Center, also says the JAMA paper should not prompt many hospitals to change what they're doing.
"The level of evidence, despite this negative study, still supports the larger benefit of CHG bathing [compared to] the potential downside of it." And Harris thinks "the evidence [for use of CHG] is strong."
He notes that that the Vanderbilt study was at a single medical center, didn't enroll enough ICU patients, and didn't account for clustering. Besides, he says, given the cost of treating even one infection, if CHG does prevent even five or six a year, it's worth the cost.
And regarding the cost, Harris says that purchasing prepared cloths for bathing is far more expensive than what many hospitals actually do, which is mixing CHG into a bathing basin. "The cost with that method is actually very little," he says.
Remember the Basics
Vicki Allen, infection control preventionist coordinator at Beaufort Memorial Hospital in Beaufort, SC, echoes Harris's advice. "I wouldn't jump to make changes. It's one study—from a very reputable author and facility, but it's one study," she says.
First and foremost, Allen says, hospitals should employ "basic strategies like hand hygiene, and follow recommendations for insertion and maintenance of lines and devices, and environmental issues. Those are the very least things that you're expected to do, and then, if you have a problem beyond that, you consider bringing in other items such as CHG for daily bathing," says Allen, who is also vice chair of the communication committee for the Association for Professionals in Infection Control and Epidemiology.
HAIs 'Not Just a Nursing Problem'
Peter Pronovost, MD, senior vice president for patient safety and quality at Johns Hopkins Hospital who developed a protocol for preventing CLABSI, agrees that the study will prompt debate. But he says it also should serve as a good reminder about the importance in infection control of "doing the basics."
"Even when we were doing our CLABSI work, people wanted to jump to the newest technology of impregnated catheters, and other technologies, when we weren't doing the basic stuff like washing your hands," Pronovost says.