Community Central Line Infection Prevention Trial

Study Design and Population: The proposed study will use a cluster-randomized, 2 period crossover design, clinical trial to evaluate a promising new intervention, namely 70% isopropyl alcohol embedded protective caps, to reduce CLABSIs, 2ndry BSI, and SPBC at home for chronic central lines in pediatric hematology/oncology patients. The Control Arm will involve "usual care" for ambulatory central lines per institutional policy and the Intervention Arm will add use of 70% isopropyl alcohol embedded protective caps to "usual care. Each participating institution will be randomly assigned to either the intervention or control phase of the design for the first 12 months of the study. There will then be a 3 month wash out period, followed by each institution then implementing either the control or intervention phase for another 12 months such that each institution will complete 12 months each in the intervention arm and the control arms of the study.

Sixteen pediatric hematology/oncology institutions will serve as the core population for this proposal and unit of randomization. All ambulatory patients taken care of by these pediatric hematology/oncology clinics at these institutions will be eligible for this study. The only inclusion criteria will be presence of an external central line. Given the intervention is a protective cap for central line access ports, patients who only have a totally implanted port as their central venous access will not be eligible for this study as the intervention is not physically applicable to such central lines.

The intervention the investigators will deploy is the CUROS® brand of 70% isopropyl alcohol embedded protective caps for central lines. These caps are manufactured by Ivera Medical Corporation. As in kind contribution to this proposed study, Ivera Medical Corporation has agreed to donate and distribute all needed CUROS® caps to the participating institutions for the duration of this study. If any of the participating teams wishes to instead use a comparable brand of 70% isopropyl alcohol embedded protective caps for central lines that will be permitted.

Distribution of the CUROS® caps will be accomplished within the clinics of each participating institution and compliance with the intervention at homes will be monitored by clinic staff via tracking counts of CUROS® caps dispensed to families. Children with chronic hematologic/oncologic conditions are seen frequently in clinic, often up to every week. Clinic staff can distribute and track volume of CUROS® caps dispensed to each family/patient, with the family/patient can report back each visit on the volume of CUROS® caps utilized. This will ensure reliable distribution to the families/patients, provide a face to face educational opportunity to ensure proper application of the CUROS® cap, and provide compliance opportunities via counts of CUROS® caps utilized.

This proposal will involve a cluster-randomized, 2 period crossover design, clinical trial. Given this proposal's focus on reducing central line infections at home, the main facilitators of best practice use of these caps at home will be the families and patients themselves. The research team will spread the needed additional education, tools, data, analyses, and support for this proposal.