N/A
N=119
Parafilm to Prevent CLABSI in Pediatric Patients Undergoing HCT
Central Line Associated Bloodstream Infections (CLABSI) · Bone Marrow Transplant
Bottom Line
View on ClinicalTrials.gov: NCT02575079 ↗Enrolled (actual)
119
Serious AEs
6.3%
Results posted
Jun 2019
Primary outcome: Primary: Rate of Central Line Associated Bloodstream Infections (CLABSI) — 3.69; 4.37 CLABSI/1000 catheter-days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Parafilm (Device)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Central Line Associated Bloodstream Infections (CLABSI) |
3.69; 4.37 | — |
| PRIMARY Reported Inpatient Percentage of Central-line Days With Correctly Applied Parafilm |
65.2 | — |
| PRIMARY Observed Inpatient Percentage of Catheter-days With Correctly Applied Parafilm |
— | — |
| PRIMARY Reported Outpatient Percentage of Catheter-days With Correctly Applied Parafilm |
64.7 | — |
| PRIMARY Observed Outpatient Percentage of Catheter-days With Correctly Applied Parafilm |
— | — |
| SECONDARY Number of Antibiotic Treatment Courses Per Participant |
— | — |
| SECONDARY Duration of Antibiotic Treatment Exposure |
— | — |
| SECONDARY Number of ICU Admissions Secondary to Sepsis |
8 | — |
| SECONDARY Death |
0; 3 | — |
| SECONDARY Perception of Parafilm |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02575079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.