This randomized trial studies 70% isopropyl alcohol-embedded protective caps in reducing central line-associated blood stream infections (CLABSI) in younger patients with diseases and disorders of the blood and blood-forming tissues (hematologic/oncologic conditions) at home. Chemotherapy regimens are usually given to patients through implanted or non-implanted central lines and unfortunately, these central lines may put many immune-compromised patients at risk for CLABSIs that often put patient's life at risk and costly medical care. The use of 70% isopropyl alcohol-embedded protective caps on day to day maintenance care of central lines has shown to be effective in reducing CLABSIs in hospital setting and may be effective in reducing CLABSIs in a home setting and potentially reduce hospitalization and costly medical care.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02351258.
PRIMARY OBJECTIVES:
I. To evaluate whether use of 70% isopropyl alcohol embedded protective caps on central lines reduces the rate of CLABSI in ambulatory pediatric hematology/oncology patients.
II. To evaluate whether use of 70% isopropyl alcohol embedded protective caps on central lines reduces the rate of all positive blood cultures in ambulatory pediatric hematology/oncology patients.
III. To evaluate whether the use of 70% isopropyl alcohol embedded protective caps on central lines changes the distribution of bacteria isolated from blood cultures of pediatric hematology/oncology patients.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients and/or caregivers replace a new 70% isopropyl alcohol embedded protective cap via luer-lock placement onto the central line every 7 days for 12 months while patients are in the ambulatory setting (e.g. home, school, work, etc). Patients then crossover to Arm II.
ARM II: Patients and/or caregivers care for the patient's central line per individual institutional policy for 12 months while patients are in the ambulatory setting. Patients then crossover to Arm I.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorMarlene Miller
