Aaron M Milstone1,2,3, Carol Rosenberg4,5, Gayane Yenokyan6, Danielle W Koontz1, Marlene R Miller4,7,8. 1. Department of Pediatrics, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland. 2. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland. 3. Department of Hospital Epidemiology and Infection Control, The Johns Hopkins Hospital, Baltimore, Maryland. 4. Department of Pediatrics, Division of Quality and Safety, Johns Hopkins University School of Medicine, Baltimore, Maryland. 5. Present affiliation: Children's Hospital Association (current), Washington, DC. 6. Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland. 7. Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland. 8. Present affiliation: Department of Pediatrics (current), UH Rainbow Babies and Children's Hospital, Cleveland, Ohio and Department of Pediatrics, Case Western Reserve University School of Medicine, Cleveland, Ohio.
Abstract
OBJECTIVE: To evaluate the effect of 70% isopropyl alcohol-impregnated central venous catheter caps on ambulatory central-line-associated bloodstream infections (CLABSIs) in pediatric hematology-oncology patients. DESIGN: This study was a 24-month, cluster-randomized, 2 period, crossover clinical trial. SETTING: The study was conducted in 15 pediatric healthcare institutions, including 16 pediatric hematology-oncology clinics. PARTICIPANTS: All patients with an external central line followed at 1 of the 16 hematology-oncology clinics. INTERVENTION: Usual ambulatory central-line care per each institution using 70% isopropyl alcohol-impregnated caps at home compared to usual ambulatory central-line care in each institution without using 70% isopropyl alcohol-impregnated caps. RESULTS: Of the 16 participating clinics, 15 clinics completed both assignment periods. As assigned, there was no reduction in CLABSI incidence in clinics using 70% isopropyl alcohol-impregnated caps (1.23 per 1,000 days) compared with standard practices (1.38 per 1,000 days; adjusted incidence rate ratio [aIRR], 0.83; 95% CI, 0.63-1.11). In the per-protocol population, there was a reduction in positive blood culture incidence in clinics using 70% isopropyl alcohol-impregnated caps (1.51 per 1,000 days) compared with standard practices (1.88 per 1,000 days; aIRR, 0.72; 95% CI, 0.52-0.99). No adverse events were reported. CONCLUSIONS: Isopropyl alcohol-impregnated central-line caps did not lead to a statistically significant reduction in CLABSI rates in ambulatory hematology-oncology patients. In the per-protocol analysis, there was a statistically significant decrease in positive blood cultures. Larger trials are needed to elucidate the impact of 70% isopropyl alcohol-impregnated caps in the ambulatory setting. REGISTRATION: ClinicalTrials.gov; NCT02351258.
OBJECTIVE: To evaluate the effect of 70% isopropyl alcohol-impregnated central venous catheter caps on ambulatory central-line-associated bloodstream infections (CLABSIs) in pediatric hematology-oncology patients. DESIGN: This study was a 24-month, cluster-randomized, 2 period, crossover clinical trial. SETTING: The study was conducted in 15 pediatric healthcare institutions, including 16 pediatric hematology-oncology clinics. PARTICIPANTS: All patients with an external central line followed at 1 of the 16 hematology-oncology clinics. INTERVENTION: Usual ambulatory central-line care per each institution using 70% isopropyl alcohol-impregnated caps at home compared to usual ambulatory central-line care in each institution without using 70% isopropyl alcohol-impregnated caps. RESULTS: Of the 16 participating clinics, 15 clinics completed both assignment periods. As assigned, there was no reduction in CLABSI incidence in clinics using 70% isopropyl alcohol-impregnated caps (1.23 per 1,000 days) compared with standard practices (1.38 per 1,000 days; adjusted incidence rate ratio [aIRR], 0.83; 95% CI, 0.63-1.11). In the per-protocol population, there was a reduction in positive blood culture incidence in clinics using 70% isopropyl alcohol-impregnated caps (1.51 per 1,000 days) compared with standard practices (1.88 per 1,000 days; aIRR, 0.72; 95% CI, 0.52-0.99). No adverse events were reported. CONCLUSIONS: Isopropyl alcohol-impregnated central-line caps did not lead to a statistically significant reduction in CLABSI rates in ambulatory hematology-oncology patients. In the per-protocol analysis, there was a statistically significant decrease in positive blood cultures. Larger trials are needed to elucidate the impact of 70% isopropyl alcohol-impregnated caps in the ambulatory setting. REGISTRATION: ClinicalTrials.gov; NCT02351258.
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