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

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.

Conflict of interest statement

Financial Disclosure: A.M.M. received prior grant support from Sage Products, Inc. and received consulting fees for BD both unrelated to this work, and receives grant support from NIH, CDC, and AHRQ unrelated to this work. J.G.C is a member of CDC’s Healthcare Infection Control Practice Advisory Committee (HICPAC). Other authors report no conflicts.

Conflicts of Interest: A.M.M. received prior grant support from Sage Products, Inc. and received consulting fees for BD both unrelated to this work, and receives grant support from NIH, CDC, and AHRQ unrelated to this work. J.G.C is a member of CDC’s Healthcare Infection Control Practice Advisory Committee (HICPAC). Other authors report no conflicts.

Figures

FIGURE 1:

Community Central Line Infection Prevention (CCLIP) Trial Flowchart. This diagram describes the recruitment and enrollment of the CCLIP Trial from November 2015 to May 2018. a Unit of randomization was the hospital, so two clinics at the same hospital were randomized to the same arm; b unable to recruit patients into trial

FIGURE 2:

Crude incidence of central line associated bloodstream infections (CLABSI). Each line represents one clinic. The slope shows the change in incidence of CLABSI between the intervention and control periods. The red line represents the change in overall crude incidence during intervention and control periods. Black lines represent clinics that had a decrease in CLABSI during the intervention period and blue lines represent clinics that did not have a decrease in CLABSI during intervention periods. Arrows indicate the assignment change from period one to period two, such that an arrow pointing to the intervention side indicates that the unit was assigned to control in period 1 and crossed over to intervention in period 2.