Passive Disinfection Cap Compliance Study

NCT03391960 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2024-10-02

Study results available
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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.

Conditions

  • Infection, Hospital

Interventions

DEVICE

Passive disinfection device

Add use of passive disinfection cap to existing central line needleless connector infection control procedure

Sponsors & Collaborators

  • Eurotrials Brasil Consultores Cientificos Ltda

    collaborator INDUSTRY
  • 3M

    collaborator INDUSTRY
  • Solventum US LLC

    lead INDUSTRY

Principal Investigators

  • Ricardo A Zimerman, MD · Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2018-10-31
Completion
2018-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03391960 on ClinicalTrials.gov