Expired Study
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Atlanta, Georgia 30322


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

IRB00080344


NCT ID:

NCT02575079


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

21 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Emory University


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

119


Enrollment Type:

Actual


Overall Contact Information

Official Name:Lakshmanan Krishnamurti, MD
Principal Investigator
Emory University

Study Dates

Start Date:March 2015
Completion Date:March 29, 2018
Completion Type:Actual
Primary Completion Date:March 29, 2018
Primary Completion Type:Actual
Verification Date:June 2019
Last Changed Date:June 6, 2019
First Received Date:October 12, 2015
First Results Date:March 29, 2019

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Perception of Parafilm
Time Frame:Month 3 (average time till removal of CVC)
Safety Issues:False
Description:The perception of parafilm from provider and caregiver surveys regarding parafilm ease of use, perceived benefit, and other parameters will be reported
Outcome Type:Secondary Outcome
Measure:Death
Time Frame:Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end o
Safety Issues:False
Description:Deaths from infection and death from any cause among participants in the parafilm study are reported.
Outcome Type:Secondary Outcome
Measure: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 o
Safety Issues:False
Description:The cumulative number of ICU admissions secondary to sepsis among participants in the parafilm study is reported.
Outcome Type:Secondary Outcome
Measure: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 o
Safety Issues:False
Description:Total duration of antibiotic treatment exposure (excluding prophylactic antibiotics) among participants in the parafilm study will be reported.
Outcome Type:Secondary Outcome
Measure: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 o
Safety Issues:False
Description:The number of antibiotic treatment courses per participant in the parafilm study will be recorded.
Outcome Type:Primary Outcome
Measure: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 expecte
Safety Issues:False
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 c
Outcome Type:Primary Outcome
Measure: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 o
Safety Issues:False
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 c
Outcome Type:Primary Outcome
Measure: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) rem
Safety Issues:False
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
Outcome Type:Primary Outcome
Measure:Reported Inpatient Percentage of Central-line Days With Correctly Applied Parafilm
Time Frame:At discharge (an expected average of 6 weeks from admission)
Safety Issues:False
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 on
Outcome Type: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 o
Safety Issues:False
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

Study Interventions

Intervention Type:Device
Name:Parafilm
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.
Arm Name:Parafilm

Study Arms

Study Arm Type:No Intervention
Arm Name:Historical Cohort
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.
Study Arm Type:Experimental
Arm Name:Parafilm
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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Emory University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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.

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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