Passive Disinfection Cap Compliance Study

A Compliance Improvement Project to Reduce Central Line Associated Blood Stream Infection (CLABSI) Using a Passive Disinfection Device in an Adult Oncological Hospital in Brazil

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.

Study Overview

• Status: Completed
• Conditions: Infection, Hospital
• Intervention / Treatment: Device: Passive disinfection device

Detailed Description

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.

Compliance is defined as following the protocol for disinfection of the catheter port. In the pre-intervention period, the disinfection protocol will utilize existing institution scrub-the-hub method. Compliance in the pre-intervention period will be determined by survey.

After the pre-intervention period is complete, passive disinfecting devices (caps) will be implemented hospital-wide for any adult patient using CVC ports.

In the intervention period, the disinfection protocol consists of using the disinfecting barrier cap on every needless connector (catheter port) used for accessing CVC IV lines per protocol. Compliance will be measured using observations, according to a schedule to ensure the absence of a shift bias. Observations will contain the number of needless connectors on CVCs with, and the number of needleless connectors without, disinfecting barrier caps attached.

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.

Incidence of CLABSI will be noted from existing aggregate hospital surveillance system data. The incidence, in terms of catheter days, will be recorded for each assigned intervention ward and for intervention ward overall by month, in the six months before the intervention and in the six-month intervention recording period.

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Maplewood, Minnesota, United States, 55144
      • 3M HealthCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Disinfecting barrier cap; In the participating wards, disinfecting barrier cap was used on every needless connector used for accessing CVC IV lines. Compliance with disinfecting barrier cap was observed weekly.	Device: Passive disinfection device; Add use of passive disinfection cap to existing central line needleless connector infection control procedure; Other Names: Passive disinfecting cap; Disinfecting cap; Curos disinfecting cap; Curos cap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disinfecting Barrier Cap Compliance	Compliance to disinfection protocol for central line needleless connectors. Compliance will be measured by periodic audits, where the number of disinfecting caps on central line needleless connectors is compared to the total number of central line needleless connectors to determine compliance percentage.	6-month prospective period
Scrub the Hub Protocol Compliance	Compliance with Scrub the hub protocol Data collected retrospectively by survey	6-month retrospective period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CLABSI Rate	Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments to determine the CLABSI rate per 1000 CVC/days. Infections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access	6-month retrospective period and 6-month prospective period
Catheter-associated Urinary Tract Infection (CAUTI) Rate	Rate of CAUTI per 1000 indwelling urinary catheter days. CAUTI data was recorded to control for possible seasonal and/or environmental effects that could also influence CLABSI and hospital infection rates overall. Data on this type of infection was only available for the ICU, as recording of CAUTI is only mandatory in the intensive care setting in Brazil.	6 months pre-intervention and 6 months post intervention
Ventilator-associated Pneumonia (VAP) Rate	Rate of VAP per 1000 ventilator days. VAP data was recorded to control for possible seasonal and/or environmental effects that could also influence CLABSI and hospital infection rates overall. Data on this type of infection was only available for the ICU, as recording of VAP is only mandatory in the intensive care setting in Brazil.	6-month retrospective period and 6-month prospective period
MBI-Related CLABSI Rate	Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments. Lastly, CLABSIs were divided into mucosal-barrier injury (MBI)-related and non-MBI-related and recorded separately in the eCRF. MBI-related CLABSIs and CVC/day were used to determine MBI CLABSI rate per 1000 CVC/days. Infections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access.	6-month retrospective period and 6-month prospective period
Non MBI-related CLABSI Rate	Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments. Lastly, CLABSIs were divided into mucosal-barrier injury (MBI)-related and non-MBI-related and recorded separately in the eCRF. Non MBI-related CLABSIs and CVC/day were used to determine Non-MBI CLABSI rate per 1000 CVC/days. Infections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access.	6-month retrospective period and 6-month prospective period

Collaborators and Investigators

• Sponsor: 3M
• Collaborators: Eurotrials Brasil Consultores Cientificos Ltda
• Investigators: Principal Investigator: Ricardo A Zimerman, MD, Irmandade da Santa Casa de Misericórdia de Porto Alegre - ISCMPA

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: December 7, 2017
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (Actual): January 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Bloodstream infection; CLABSI; Septicemia; Central line associated bloodstream infection; Catheter related bloodstream infection; Intravascular device; Catheter port
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Iatrogenic Disease; Infections; Communicable Diseases; Cross Infection
• Other Study ID Numbers: CLIN-PROT-ICH-US-05-319980; Study 05-014137 (Other Identifier: 3M)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No individual participant data will be recorded in the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes