Back to resultsParafilm to Prevent CLABSI in Pediatric Patients Undergoing HCT
Primary Purpose
Central Line Associated Bloodstream Infections (CLABSI), Bone Marrow Transplant
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parafilm
Sponsored by
About this trial
This is an interventional prevention trial for Central Line Associated Bloodstream Infections (CLABSI)
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
Sites / Locations
- Children's Healthcare of Atlanta
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Parafilm
Historical Cohort
Arm Description
Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) will have pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected). Parafilm will be maintained on the CVC and routine CVC care will be continued, per institutional standard of practice, until the CVC is removed.
Pediatric patients receiving hematopoietic cell transplantation in the 16 months preceding the study intervention. Data were obtained retrospectively through medical records for the purpose of comparing CLABSI rates among recipients of parafilm to a control group.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Number of Antibiotic Treatment Courses Per Participant
The number of antibiotic treatment courses per participant in the parafilm study will be recorded.
Duration of Antibiotic Treatment Exposure
Total duration of antibiotic treatment exposure (excluding prophylactic antibiotics) among participants in the parafilm study will be reported.
Number of ICU Admissions Secondary to Sepsis
The cumulative number of ICU admissions secondary to sepsis among participants in the parafilm study is reported.
Death
Deaths from infection and death from any cause among participants in the parafilm study are reported.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02575079
Brief Title
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
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 29, 2018 (Actual)
Study Completion Date
March 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Line Associated Bloodstream Infections (CLABSI), Bone Marrow Transplant
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parafilm
Arm Type
Experimental
Arm Description
Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) will have pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected). Parafilm will be maintained on the CVC and routine CVC care will be continued, per institutional standard of practice, until the CVC is removed.
Arm Title
Historical Cohort
Arm Type
No Intervention
Arm Description
Pediatric patients receiving hematopoietic cell transplantation in the 16 months preceding the study intervention. Data were obtained retrospectively through medical records for the purpose of comparing CLABSI rates among recipients of parafilm to a control group.
Intervention Type
Device
Intervention Name(s)
Parafilm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Central Line Associated Bloodstream Infections (CLABSI)
Description
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)
Title
Reported Inpatient Percentage of Central-line Days With Correctly Applied Parafilm
Description
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)
Title
Observed Inpatient Percentage of Catheter-days With Correctly Applied Parafilm
Description
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.
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)
Title
Reported Outpatient Percentage of Catheter-days With Correctly Applied Parafilm
Description
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)
Title
Observed Outpatient Percentage of Catheter-days With Correctly Applied Parafilm
Description
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)
Secondary Outcome Measure Information:
Title
Number of Antibiotic Treatment Courses Per Participant
Description
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)
Title
Duration of Antibiotic Treatment Exposure
Description
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)
Title
Number of ICU Admissions Secondary to Sepsis
Description
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)
Title
Death
Description
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)
Title
Perception of Parafilm
Description
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)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lakshmanan Krishnamurti, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Citations:
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.
Results Reference
result
Learn more about this trial
Parafilm to Prevent CLABSI in Pediatric Patients Undergoing HCT
We'll reach out to this number within 24 hrs