The purpose of this study is to see if applying parafilm as an external barrier on the central line in children having a bone marrow transplant helps to prevent central line associated bloodstream infection(s) and also to assess the ease of use of parafilm.
Central line associated bloodstream infections (CLABSI) result in significant morbidity and mortality, particularly in patients undergoing hematopoietic cell transplantation (HCT). HCT patients are at high risk for CLABSI due to multiple factors, including prolonged immune suppression and the need for long-term central venous access. The investigators want to assess the feasibility of the use of a parafilm central line barrier (parafilm) as standard of care in pediatric HCT patients. The investigators will also assess the effectiveness of the parafilm to reduce the incidence of CLABSI in these patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
119
Single-use, pre-cut sections of parafilm over the central venous catheter (CVC) hub (if not connected) or around the CVC hub connection (if connected). Parafilm will be maintained on the CVC until it is removed.
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Rate of Central Line Associated Bloodstream Infections (CLABSI)
Central line associated bloodstream infections (CLABSI) is the identification of a bacterial infection from a blood culture drawn from a central venous catheter (CVC) in the absence of a primary source of infection from another body site. The CLABSI rate (total number of CLABSI/1000 catheter-days) in parafilm study participants will be calculated and compared to the CLABSI rate in a historical cohort of pediatric patients who are serving as a control group.
Time frame: Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)
Reported Inpatient Percentage of Central-line Days With Correctly Applied Parafilm
In the inpatient setting, compliance was measured by once daily recording of parafilm change by nursing in the electronic medical record. These data were significantly limited by electronic medical record charting on parafilm change being required only once per day. Thus, once daily data collection failed to capture daily parafilm change, given multiple nursing shifts on a single calendar day. Nonetheless, the percentage of catheter-days with intact correctly applied parafilm, as reported by nursing staff, was calculated.
Time frame: At discharge (an expected average of 6 weeks from admission)
Observed Inpatient Percentage of Catheter-days With Correctly Applied Parafilm
Observed compliance occurred during weekly line rounds. Rounding providers indicated whether a patient's parafilm is intact and correctly applied, not applied, or incorrectly applied or not intact. The percentage of "observed catheter-days" where patients had correct use of intact parafilm were to be calculated. To track observed inpatient compliance with applying parafilm, data fields were added to the entered to the nursing charts of the participant's electronic medical record (EMR). The primary field added was a no/question about parafilm applied. Per study protocol, the intent was to document nursing changing of the parafilm, at the time it was changed. However, on reviewing the data, it appears that nursing just charted once per day whether they had changed parafilm or not, while the parafilm may have been changed earlier by a different nurse.
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Time frame: Time between initial bone marrow transplant (BMT) discharge and either central venous line (CVL) removal or transfer back to primary MD (an expected average of 2-3 months)
Reported Outpatient Percentage of Catheter-days With Correctly Applied Parafilm
For outpatient reported compliance, parents of study participants provided their logs to outpatient staff who documented the number of days parafilm was correctly in use/intact vs not in use or incorrectly in use/not intact. The cumulative percentage of catheter-days where parafilm was intact was calculated.
Time frame: Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)
Observed Outpatient Percentage of Catheter-days With Correctly Applied Parafilm
For observed compliance, the outpatient nurse recorded whether the patient's parafilm was correctly applied/intact (yes), not applied (no), or incorrectly applied/not intact (yes-inc) at the beginning of the visit. The percentage of outpatient "observed catheter-days" where parafilm was correctly in use/intact was calculated.
Time frame: Time between initial BMT discharge and either CVL removal or transfer back to primary MD (an expected average of 2-3 months)
Number of Antibiotic Treatment Courses Per Participant
The number of antibiotic treatment courses per participant in the parafilm study will be recorded.
Time frame: Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)
Duration of Antibiotic Treatment Exposure
Total duration of antibiotic treatment exposure (excluding prophylactic antibiotics) among participants in the parafilm study will be reported.
Time frame: Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)
Number of ICU Admissions Secondary to Sepsis
The cumulative number of ICU admissions secondary to sepsis among participants in the parafilm study is reported.
Time frame: Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)
Death
Deaths from infection and death from any cause among participants in the parafilm study are reported.
Time frame: Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)
Perception of Parafilm
The perception of parafilm from provider and caregiver surveys regarding parafilm ease of use, perceived benefit, and other parameters will be reported
Time frame: Month 3 (average time till removal of CVC)