N/A
N=165
Passive Disinfection Cap Compliance Study
Infection, Hospital
Bottom Line
View on ClinicalTrials.gov: NCT03391960 ↗Enrolled (actual)
165
Serious AEs
—
Results posted
Feb 2022
Primary outcome: Primary: Disinfecting Barrier Cap Compliance — 98.43 percentage of connector with compliance
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Passive disinfection device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Solventum US LLC
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disinfecting Barrier Cap Compliance |
98.43 | — |
| PRIMARY Scrub the Hub Protocol Compliance |
5.95 | — |
| SECONDARY CLABSI Rate |
2.9; 3.2 | — |
| SECONDARY Catheter-associated Urinary Tract Infection (CAUTI) Rate |
0.78; 2.26 | — |
| SECONDARY Ventilator-associated Pneumonia (VAP) Rate |
6.2; 5.35 | — |
| SECONDARY MBI-Related CLABSI Rate |
1; 1.28 | — |
| SECONDARY Non MBI-related CLABSI Rate |
1.93; 1.92 | — |
Summary
Insertion and maintenance of central venous catheter (CVC) lines are common hospital procedures in patients, including those being treated for cancer. CVCs allow clinicians an access point for infusion of fluids, blood sampling, and measurements, decreasing the need for repeated needle sticks to the patient. However, bloodstream infections associated with CVCs (CLABSIs) are a serious complication, leading to significantly longer hospital stays, morbidity, and mortality. Keeping catheter ports disinfected reduces the risk of bloodstream infection; however, consistent and adequate maintenance and disinfection of the line can be difficult.
The purpose of this study is to demonstrate that passive disinfecting caps can provide a patient safety practice that is easy for clinicians to follow, as well as providing easily auditable compliance, which may lead to lower CLABSI rates.
The compliance rate for needleless connector disinfection will be evaluated after implementation of the passive disinfecting cap, and compared to the pre-intervention rate. The CLABSI rates before and after cap implementation will also be compared.
Eligibility Criteria
Inclusion Criteria
- Adult patients admitted to the participant oncologic hospital
- Adult patients in the assigned intervention units during the seven month intervention period who require needleless connectors for CVC IV tubing access.
Exclusion Criteria
- Adult patients admitted to the participant oncologic hospital during the seven month intervention period that do not require needleless connectors for CVC IV access during their hospital stay.
Data sourced from ClinicalTrials.gov (NCT03391960). 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.