Trial Outcomes & Findings for Parafilm to Prevent CLABSI in Pediatric Patients Undergoing HCT (NCT NCT02575079)
NCT ID: NCT02575079
Last Updated: 2019-06-25
Results Overview
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.
COMPLETED
NA
119 participants
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)
2019-06-25
Participant Flow
Participants were enrolled in the parafilm study between March 2015 and June 2017. All study procedures and follow up was completed on March 29, 2018.
Fifty-one individuals consented to participate in the study. Prior to beginning any study interventions one was lost to follow up, one withdrew, and one did not begin the prep regimen, resulting in 48 participants who began the study intervention.
Participant milestones
| Measure |
Parafilm
Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
|
Historical Cohort
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.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
71
|
|
Overall Study
COMPLETED
|
42
|
71
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
| Measure |
Parafilm
Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
|
Historical Cohort
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.
|
|---|---|---|
|
Overall Study
Death
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Parafilm to Prevent CLABSI in Pediatric Patients Undergoing HCT
Baseline characteristics by cohort
| Measure |
Parafilm
n=48 Participants
Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
|
Historical Cohort
n=71 Participants
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.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age in years · Less than or equal to 2 years
|
7 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
|
Age, Customized
Age in years · Between 3 and 9 years
|
25 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
47 Participants
n=35 Participants
|
|
Age, Customized
Age in years · Between 10 and 21 years
|
16 Participants
n=39 Participants
|
28 Participants
n=41 Participants
|
44 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
42 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=39 Participants
|
46 Participants
n=41 Participants
|
77 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=39 Participants
|
65 Participants
n=41 Participants
|
105 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
0 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Black or African American
|
21 Participants
n=39 Participants
|
32 Participants
n=41 Participants
|
53 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
25 Participants
n=39 Participants
|
34 Participants
n=41 Participants
|
59 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=39 Participants
|
71 participants
n=41 Participants
|
119 participants
n=35 Participants
|
|
Type of HCT
Allogeneic
|
35 Participants
n=39 Participants
|
49 Participants
n=41 Participants
|
84 Participants
n=35 Participants
|
|
Type of HCT
Autologous
|
13 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
35 Participants
n=35 Participants
|
|
Underlying disease
Malignant, hematologic
|
17 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
41 Participants
n=35 Participants
|
|
Underlying disease
Malignant, solid tumor
|
12 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
33 Participants
n=35 Participants
|
|
Underlying disease
Non-malignant
|
19 Participants
n=39 Participants
|
26 Participants
n=41 Participants
|
45 Participants
n=35 Participants
|
PRIMARY outcome
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)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.
Outcome measures
| Measure |
Parafilm
n=48 Participants
Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
|
Historical Cohort
n=71 Participants
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.
|
|---|---|---|
|
Rate of Central Line Associated Bloodstream Infections (CLABSI)
|
3.69 CLABSI/1000 catheter-days
Interval 2.19 to 5.83
|
4.37 CLABSI/1000 catheter-days
Interval 2.86 to 6.4
|
PRIMARY outcome
Timeframe: At discharge (an expected average of 6 weeks from admission)Population: Participants in the parafilm study are included in this analysis. Percentage of inpatient days where nursing charted parafilm change in the electronic medical record is reported for the entire parafilm cohort.
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.
Outcome measures
| Measure |
Parafilm
n=48 Participants
Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
|
Historical Cohort
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.
|
|---|---|---|
|
Reported Inpatient Percentage of Central-line Days With Correctly Applied Parafilm
|
65.2 percentage of central-line days
|
—
|
PRIMARY outcome
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)Population: The data collected indicated that nursing staff did not understand how the parafilm monitoring needed to be charted for the purposes of data analysis. Although a data field was created in the EMR, in practice, the data collected was not an accurate assessment of parafilm use, thus no data are available for analysis of this outcome measure.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
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)Population: The population used for this analysis consists of caretakers who returned outpatient logs of parafilm use at the end of the study. Forty-one participants used parafilm in the outpatient setting and of these 34 returned the outpatient logs.
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.
Outcome measures
| Measure |
Parafilm
n=34 Participants
Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
|
Historical Cohort
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.
|
|---|---|---|
|
Reported Outpatient Percentage of Catheter-days With Correctly Applied Parafilm
|
64.7 percent of catheter-days
|
—
|
PRIMARY outcome
Timeframe: Time between initial BMT discharge and either CVL removal or transfer back to primary MD (an expected average of 2-3 months)Population: Observed outpatient compliance was not performed as it was difficult to implement this in a busy clinic setting.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
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)Population: Data on antibiotic treatment courses were not collected.
The number of antibiotic treatment courses per participant in the parafilm study will be recorded.
Outcome measures
Outcome data not reported
SECONDARY outcome
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)Population: Data on duration of antibiotic treatments were not collected.
Total duration of antibiotic treatment exposure (excluding prophylactic antibiotics) among participants in the parafilm study will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
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)Population: Participants in the parafilm study are included in this analysis.
The cumulative number of ICU admissions secondary to sepsis among participants in the parafilm study is reported.
Outcome measures
| Measure |
Parafilm
n=48 Participants
Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
|
Historical Cohort
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.
|
|---|---|---|
|
Number of ICU Admissions Secondary to Sepsis
|
8 ICU admissions
|
—
|
SECONDARY outcome
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)Population: Participants in the parafilm study are included in this analysis.
Deaths from infection and death from any cause among participants in the parafilm study are reported.
Outcome measures
| Measure |
Parafilm
n=48 Participants
Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
|
Historical Cohort
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.
|
|---|---|---|
|
Death
Death from infection
|
0 Participants
|
—
|
|
Death
Death from any cause
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Month 3 (average time till removal of CVC)Population: A survey was initially planned for in the protocol but was removed from the study procedures prior to any participants completing the survey.
The perception of parafilm from provider and caregiver surveys regarding parafilm ease of use, perceived benefit, and other parameters will be reported
Outcome measures
Outcome data not reported
Adverse Events
Parafilm
Serious adverse events
| Measure |
Parafilm
n=48 participants at risk
Pediatric patients undergoing hematopoietic stem cell transplant (HCT) with central venous catheters (CVCs) who had pre-cut, single-use sections of parafilm applied over the CVC hub (if not connected) or around the CVC hub connection (if connected).
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute hypoxemic respiratory failure
|
2.1%
1/48 • Number of events 1 • Adverse events were collected from the time a participant entered the study until CVC removal (3 months on average).
Adverse events will be described using event terms and severity grading from the National Cancer Institute (NCI) CTCAE version 4.0. Adverse events will be characterized by severity grading, attribution (relationship to study treatment), and expectedness (based upon prior experience). Only unexpected serious adverse events and serious adverse events related to the study intervention were collected. Non-serious adverse events were not collected.
|
|
Immune system disorders
Graft versus host disease (GVHD)
|
4.2%
2/48 • Number of events 2 • Adverse events were collected from the time a participant entered the study until CVC removal (3 months on average).
Adverse events will be described using event terms and severity grading from the National Cancer Institute (NCI) CTCAE version 4.0. Adverse events will be characterized by severity grading, attribution (relationship to study treatment), and expectedness (based upon prior experience). Only unexpected serious adverse events and serious adverse events related to the study intervention were collected. Non-serious adverse events were not collected.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place