Clinical trial NCT02575079: Parafilm to Prevent CLABSI in Pediatric Patients Undergoing HCT
Official title: Parafilm Application to Prevent Central Line Associated Bloodstream Infections in Pediatric Patients Undergoing Hematopoietic Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Line Associated Bloodstream Infections (CLABSI)
Bone Marrow Transplant
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-10-14
Enrollment: 119
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1 is comprised of study participants receiving parafilm applied over the CVC hub or around the CVC hub connection. Arm 2 is a retrospective historical cohort of pediatric patients receiving HCT for the purpose of comparing CLABSI rates.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Must be between the age of 0 and 21 years at the time of enrollment
* Must be undergoing allogeneic or autologous HCT for a malignant or non-malignant disorder
* Must have or be scheduled to have a tunneled CVC

Exclusion Criteria:

* Patients undergoing other interventions to prevent CLABSI (e.g. Children's Oncology Group (COG) study ACCL1034 with Chlorhexidine Gluconate (CHG); antimicrobial lock therapy, etc.)
* Patients who only have a port

Primary outcomes:
measure: Rate of Central Line Associated Bloodstream Infections (CLABSI)
timeFrame: 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)
measure: Reported Inpatient Percentage of Central-line Days With Correctly Applied Parafilm
timeFrame: At discharge (an expected average of 6 weeks from admission)
measure: Observed Inpatient Percentage of Catheter-days With Correctly Applied Parafilm
timeFrame: 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)
measure: Reported Outpatient Percentage of Catheter-days With Correctly Applied Parafilm
timeFrame: 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)
measure: Observed Outpatient Percentage of Catheter-days With Correctly Applied Parafilm
timeFrame: Time between initial BMT discharge and either CVL removal or transfer back to primary MD (an expected average of 2-3 months)
Secondary outcomes:
measure: Number of Antibiotic Treatment Courses Per Participant
timeFrame: 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)
measure: Duration of Antibiotic Treatment Exposure
timeFrame: 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)
measure: Number of ICU Admissions Secondary to Sepsis
timeFrame: 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)
measure: Death
timeFrame: 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)
measure: Perception of Parafilm
timeFrame: Month 3 (average time till removal of CVC)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Lakshmanan Krishnamurti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stenger EO, Newton JG, Leong T, Kendrick L, McManus L, Rooke C, Krishnamurti L. Application of parafilm as a physical barrier on CVC connections is feasible and may reduce CLABSI among pediatric HCT patients. Biology of Blood Marrow Transplantation 25 (Suppl 3): S131, 2019.