Central Line Associated Bloodstream Infections (CLABSI)NCT02575079

Parafilm to Prevent CLABSI in Pediatric Patients Undergoing HCT

A study testing Parafilm in people with Central Line Associated Bloodstream Infections (CLABSI) and Bone Marrow Transplant, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages Up to 21 years
Conditions the study is for: Central Line Associated Bloodstream Infections (CLABSI), Bone Marrow Transplant
What is being tested?: Parafilm
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 119 participants
Where: 1 siteUnited States
Study dates: Mar 2015to 29 Mar 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Healthcare of Atlanta
Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Parafilm Application to Prevent Central Line Associated Bloodstream Infections in Pediatric Patients Undergoing Hematopoietic Cell Transplantation

Read the 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.

Conditions: Central Line Associated Bloodstream Infections (CLABSI), Bone Marrow Transplant
Being tested: Parafilm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ParafilmDevice
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.

Study groups in NCT02575079
Study group	Role	What they receive
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. Receives: Device: Parafilm
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Time between initial BMT discharge and either CVL removal or transfer back to primary MD (an expected average of 2-3 months)

Secondary outcomes (5)

Number of Antibiotic Treatment Courses Per Participant
The number of antibiotic treatment courses per participant in the parafilm study will be recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Month 3 (average time till removal of CVC)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 201529 Mar 2018

First posted14 Oct 2015 (estimated)
Study startMar 2015
Primary completion29 Mar 2018
Study completion29 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Central Line Associated Bloodstream Infections (CLABSI)Studies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
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)
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02575079
Sponsor's protocol ID: IRB00080344
Status last verified: Jun 2019
First submitted: 12 Oct 2015
Last updated: 25 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Central Line Associated Bloodstream Infections (CLABSI) trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Parafilm Application to Prevent Central Line Associated Bloodstream Infections in Pediatric Patients Undergoing Hematopoietic Cell Transplantation
ClinicalTrials.gov ID: NCT02575079
Acronym / sponsor ID: IRB00080344
Conditions: Central Line Associated Bloodstream Infections (CLABSI), Bone Marrow Transplant
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Study start: Mar 2015
Primary completion: 29 Mar 2018 (actual)
Study completion: 29 Mar 2018 (actual)
First posted: 14 Oct 2015 (estimated)
Results: Posted 25 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Parafilm	Experimental	Device: ParafilmPediatric 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.

Who may qualify

Ages: Up to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ParafilmSingle-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.	Device	Parafilm

Primary outcome

Rate of Central Line Associated Bloodstream Infections (CLABSI)
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)
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
Time frame: At discharge (an expected average of 6 weeks from admission)
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
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)
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
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)
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
Time frame: Time between initial BMT discharge and either CVL removal or transfer back to primary MD (an expected average of 2-3 months)
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.

5 secondary outcomes

Number of Antibiotic Treatment Courses Per Participant
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
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
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
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
Time frame: Month 3 (average time till removal of CVC)

Results and safety

Results posted to the registry on 25 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Parafilm	48	42
Historical Cohort	71	71

Primary outcome: Rate of Central Line Associated Bloodstream Infections (CLABSI)

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 (95% Confidence Interval). Unit: CLABSI/1000 catheter-days

Measure	Parafilm n = 48	Historical Cohort n = 71
Value	3.69 (2.19 to 5.83)	4.37 (2.86 to 6.40)

Primary outcome: Reported Inpatient Percentage of Central-line Days With Correctly Applied Parafilm

Time frame: At discharge (an expected average of 6 weeks from admission). Number. Unit: percentage of central-line days

Measure	Parafilm n = 48
Value	65.2

Population analysed: 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.

Primary outcome: Observed Inpatient Percentage of Catheter-days With Correctly Applied Parafilm

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)

Population analysed: 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.

Primary outcome: Reported Outpatient Percentage of Catheter-days With Correctly Applied Parafilm

Measure	Parafilm n = 34
Value	64.7

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time a participant entered the study until CVC removal (3 months on average).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Parafilm	3 of 48 (6.3%)	0 of 0	3 of 48

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationStenger 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lakshmanan Krishnamurti, MD principal investigator

Emory University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Parafilm in people with Central Line Associated Bloodstream Infections (CLABSI) and Bone Marrow Transplant, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Central Line Associated Bloodstream Infections (CLABSI) (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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02575079, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.