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Passive Disinfection Cap Compliance Study

Primary Purpose

Infection, Hospital

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Passive disinfection device
Sponsored by
3M
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infection, Hospital focused on measuring CLABSI, Septicemia, Bloodstream infection, Central line associated bloodstream infection, Catheter related bloodstream infection, Intravascular device, Catheter port

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 3M HealthCare

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Disinfecting barrier cap

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Scrub the Hub Protocol Compliance
Compliance with Scrub the hub protocol Data collected retrospectively by survey

Secondary Outcome Measures

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
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.
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.
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.
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.

Full Information

First Posted
December 7, 2017
Last Updated
January 14, 2022
Sponsor
3M
Collaborators
Eurotrials Brasil Consultores Cientificos Ltda
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1. Study Identification

Unique Protocol Identification Number
NCT03391960
Brief Title
Passive Disinfection Cap Compliance Study
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
Collaborators
Eurotrials Brasil Consultores Cientificos Ltda

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Hospital
Keywords
CLABSI, Septicemia, Bloodstream infection, Central line associated bloodstream infection, Catheter related bloodstream infection, Intravascular device, Catheter port

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Disinfecting barrier cap
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Passive disinfection device
Other Intervention Name(s)
Passive disinfecting cap, Disinfecting cap, Curos disinfecting cap, Curos cap
Intervention Description
Add use of passive disinfection cap to existing central line needleless connector infection control procedure
Primary Outcome Measure Information:
Title
Disinfecting Barrier Cap Compliance
Description
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.
Time Frame
6-month prospective period
Title
Scrub the Hub Protocol Compliance
Description
Compliance with Scrub the hub protocol Data collected retrospectively by survey
Time Frame
6-month retrospective period
Secondary Outcome Measure Information:
Title
CLABSI Rate
Description
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
Time Frame
6-month retrospective period and 6-month prospective period
Title
Catheter-associated Urinary Tract Infection (CAUTI) Rate
Description
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.
Time Frame
6 months pre-intervention and 6 months post intervention
Title
Ventilator-associated Pneumonia (VAP) Rate
Description
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.
Time Frame
6-month retrospective period and 6-month prospective period
Title
MBI-Related CLABSI Rate
Description
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.
Time Frame
6-month retrospective period and 6-month prospective period
Title
Non MBI-related CLABSI Rate
Description
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.
Time Frame
6-month retrospective period and 6-month prospective period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo A Zimerman, MD
Organizational Affiliation
Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA
Official's Role
Principal Investigator
Facility Information:
Facility Name
3M HealthCare
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55144
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be recorded in the study.

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Passive Disinfection Cap Compliance Study

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