Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parafilm | Experimental | 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. |
|
| Historical Cohort | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parafilm | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Antibiotic Treatment Courses Per Participant | The number of antibiotic treatment courses per participant in the parafilm study will be recorded. | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lakshmanan Krishnamurti, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. |
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Historical Cohort |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | 95% Confidence Interval | CLABSI/1000 catheter-days | 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) |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute hypoxemic respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
Not provided
Assessing feasibility of outpatient parafilm use was limited by difficulty collecting parafilm compliance calendars from caretakers and observed variability of compliance in the outpatient setting.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Stenger | Emory University | 404-785-1272 | elizabeth.o'brien.stenger@emory.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2018 | Mar 18, 2019 | Prot_SAP_000.pdf |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| 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. | 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 between initial BMT discharge and either CVL removal or transfer back to primary MD (an expected average of 2-3 months) |
| Duration of Antibiotic Treatment Exposure | Total duration of antibiotic treatment exposure (excluding prophylactic antibiotics) among participants in the parafilm study will be reported. | 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. | 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. | 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 | Month 3 (average time till removal of CVC) |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of HCT | Count of Participants | Participants |
|
| Underlying disease | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Primary | 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. | 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. | Posted | Number | percentage of central-line days | At discharge (an expected average of 6 weeks from admission) |
|
|
|
| Primary | 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. | 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. | Posted | 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) |
|
|
| Primary | 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. | 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. | Posted | Number | percent of catheter-days | 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) |
|
|
|
| Primary | 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. | Observed outpatient compliance was not performed as it was difficult to implement this in a busy clinic setting. | Posted | Time between initial BMT discharge and either CVL removal or transfer back to primary MD (an expected average of 2-3 months) |
|
|
| Secondary | Number of Antibiotic Treatment Courses Per Participant | The number of antibiotic treatment courses per participant in the parafilm study will be recorded. | Data on antibiotic treatment courses were not collected. | Posted | 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) |
|
|
| Secondary | Duration of Antibiotic Treatment Exposure | Total duration of antibiotic treatment exposure (excluding prophylactic antibiotics) among participants in the parafilm study will be reported. | Data on duration of antibiotic treatments were not collected. | Posted | 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) |
|
|
| Secondary | Number of ICU Admissions Secondary to Sepsis | The cumulative number of ICU admissions secondary to sepsis among participants in the parafilm study is reported. | Participants in the parafilm study are included in this analysis. | Posted | Number | ICU admissions | 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) |
|
|
|
| Secondary | Death | Deaths from infection and death from any cause among participants in the parafilm study are reported. | Participants in the parafilm study are included in this analysis. | Posted | Count of Participants | 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) |
|
|
|
| Secondary | 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 | A survey was initially planned for in the protocol but was removed from the study procedures prior to any participants completing the survey. | Posted | Month 3 (average time till removal of CVC) |
|
|
| 3 |
| 48 |
| 3 |
| 48 |
| 0 |
| 0 |
| Graft versus host disease (GVHD) | Immune system disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided