Alcohol-impregnated caps and ambulatory central-line-associated bloodstream infections (CLABSIs): A randomized clinical trial.

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.