BOSTON – Daily bathing of pediatric patients in the intensive care unit with a chlorhexidine gluconate–containing cloth led to a statistically significant 35% reduction in the incidence of bloodstream infections in a randomized, controlled, 1-year study of more than 4,000 patients at five U.S. centers.
The results also showed a consistent 28% drop in the incidence of central line–associated bloodstream infections (CLABSI) with daily chlorhexidine gluconate baths in the pediatric ICU patients studied, although the overall rate of CLABSI was low and hence this difference was not statistically significant, Dr. Aaron M. Milstone said at the annual meeting of the Infectious Diseases Society of America.
Dr. Aaron M. Milstone
"We showed that children on this treatment had a significant reduction in bacteremias. This is dramatic, and we’re pretty excited. In our ICU we’ve agreed that the bacteremia effect is relevant and worth targeting. We have started discussions about using this [routinely] in our population," as have several of the other ICUs that participated in the study, said Dr. Milstone, a pediatric infectious diseases physician at Johns Hopkins Medical Center in Baltimore.
"When a child has a positive blood culture in the ICU, they undergo further blood culturing, they receive antibiotics for 48 hours or longer, and they remain in the ICU longer, so there are costs from these bacteremias, even if they are only contaminated blood cultures," he said in an interview. In other cases, the bloodstream infections themselves could be clinically significant and result in increased morbidity and mortality.
Additional findings from the study reported last April showed that the daily baths were safe and well tolerated, and did not produce significant adverse effects, Dr. Milstone noted.
Although the study specifically used a marketed cloth that is impregnated with 2% chlorhexidine gluconate as the delivery vehicle for the antiseptic, "I think that any chlorhexidine product may be equally effective," he said in an interview. "We used this cloth because it was convenient and easy to apply, but I think what made the difference was reducing bacteria on the [patients’] skin."
The Pediatric Scrubbing with Chlorhexidine Reduces Unwanted Bacteria (SCRUB) study ran in 10 pediatric ICUs at five U.S. medical centers. The study enrolled patients aged 2 months or older who had been in the ICU for more than 2 days. The average age of the enrolled patients varied among the ICUs, from less than 1 year at some sites to 7 years at others sites. Children were excluded from the study if they had a chlorhexidine allergy, lumbar or epidural drains, severe skin disease, or burns.
Randomization occurred among the 10 pediatric ICUs that participated. During the first 6 months of the study, five of the units routinely bathed all of the enrolled patients with chlorhexidine, and the other five used daily baths with soap and water only or with a washcloth with no added soap. After a 2-week hiatus, the ICUs switched to the other bathing method.
"We showed that children on this treatment had a significant reduction in bacteremias."
The study included 2,525 children in the control arm and 1,547 in the chlorhexidine arm in a "modified" intention-to-treat analysis. An additional 875 children initially randomized to the chlorhexidine arm never received any treatment because the researchers did not receive consent from a parent or guardian. The 1,547 children in the chlorhexidine arm included 71 patients for whom consent existed but who withdrew or were excluded.
During the study, patients had a total of 115 bloodstream infections, including 42 with CLABSI. The researchers saw a reduced number of bacteremias among the chlorhexidine-treated children at 8 of the 10 participating ICUs, showing "a consistent and robust" treatment effect, Dr. Milstone said.
The chlorhexidine treatment worked most effectively at reducing gram-positive bloodstream infections, which dropped by 46% compared with the control group, a significant difference. The researchers isolated gram-positive bacteria from 77 of the 115 (67%) bacteremic specimens.
The study was partially funded by Sage Products, which markets the chlorhexidine-impregnated cloth used in the study. Dr. Milstone said that he has no personal financial disclosures.