Passive Disinfection Cap Compliance Study

• Sponsor: 3M (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03391960
• Collaborator: Eurotrials Brasil Consultores Cientificos Ltda (Industry)
• Enrollment: 165
• Location: 1
• Arm: 1
• Actual Duration (Months): 7
• Patients Per Site Per Month: 23.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infection, Hospital	Device: Passive disinfection device	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 165 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Apr 1, 2018
• Actual Primary Completion Date: Oct 31, 2018
• Actual Study Completion Date: Oct 31, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Disinfecting Barrier Cap Compliance [6-month prospective period]

   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.

2. Scrub the Hub Protocol Compliance [6-month retrospective period]

   Compliance with Scrub the hub protocol Data collected retrospectively by survey

Secondary Outcome Measures

1. CLABSI Rate [6-month retrospective period and 6-month prospective period]

   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

2. Catheter-associated Urinary Tract Infection (CAUTI) Rate [6 months pre-intervention and 6 months post intervention]

   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.

3. Ventilator-associated Pneumonia (VAP) Rate [6-month retrospective period and 6-month prospective period]

   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.

4. MBI-Related CLABSI Rate [6-month retrospective period and 6-month prospective period]

   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.

5. Non MBI-related CLABSI Rate [6-month retrospective period and 6-month prospective period]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	3M HealthCare	Maplewood	Minnesota	United States	55144

Sponsors and Collaborators

• 3M
• Eurotrials Brasil Consultores Cientificos Ltda

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Feb 28, 2019
• Statistical Analysis Plan - Jul 24, 2019

More Information

Publications

None provided.

• Responsible Party: 3M
• ClinicalTrials.gov Identifier: NCT03391960
• Other Study ID Numbers: CLIN-PROT-ICH-US-05-319980; Study 05-014137
• First Posted: Jan 5, 2018
• Last Update Posted: Feb 9, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by 3M: CLABSI; Septicemia; Bloodstream infection; Central line associated bloodstream infection; Catheter related bloodstream infection; Intravascular device; Catheter port
• Additional relevant MeSH terms: Infections; Communicable Diseases; Cross Infection

Study Results

Participant Flow

Recruitment Details	No individual patient was recruited into the study.

Arm/Group Title	Compliance With Scrub the Hub Protocol	Compliance With Disinfecting Barrier Cap Ptotocol
Arm/Group Description	Compliance with scrub the hub protocol was retrospectively measured through a survey from Health care workers who were working in the hospital and used needleless connector	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.
Period Title: Overall Study
STARTED	165	NA
COMPLETED	165	NA
NOT COMPLETED	0	NA

Baseline Characteristics

Arm/Group Title	Not Applicable
Arm/Group Description	During the study, Baseline data were not collected for the health care workers. No individual patient was consented in the study.
Overall Participants	0
Age, Customized () []
Sex: Female, Male () []
Female
Male
Race (NIH/OMB) () []
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported
Study-Specific Measure () []

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

No patients assessed for disinfecting barrier cap compliance. Compliance with disinfecting barrier cap was measured by observation of numbers of applicable capped, uncapped ports and misused caps. A total of 156 audits were performed.

Arm/Group Title	Disinfecting Barrier Cap Compliance
Arm/Group 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.
Measure Participants	NA
Measure Compliance audits	156
Mean (Standard Deviation) [percentage of connector with compliance]	98.43 (4.18)

2. Primary Outcome

Title	Scrub the Hub Protocol Compliance
Description	Compliance with Scrub the hub protocol Data collected retrospectively by survey
Time Frame	6-month retrospective period

Outcome Measure Data

Analysis Population Description

Compliance with scrub the hub was retrospectively obtained by a survey from 165 healthcare workers who were using needlessness connectors for patient IV access. One was excluded from the compliance analysis due to an inconsistency in the survey data. No patients assessed for disinfecting barrier cap compliance.

Arm/Group Title	Scrub the Hub Protocol Compliance
Arm/Group Description	Compliance with Scrub the hub protocol Data collected by survey No individual patient's information was collected during the study
Measure Participants	164
Mean (Standard Deviation) [percentage of protocol compliance]	5.95 (21.36)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who require needleless connectors for CVC IV access or dialysis catheters in one ICU (6 units) and five non-ICU (6 units of each) wards. Total 36 units. No individual patients were enrolled in this study. No Patients assessed for this measure.

Arm/Group Title	CLABSI Rate for Pre-intervention Period	CLABSI Rate for Post-intervention Period
Arm/Group Description	Number of CLABSI infections and CVC/day recorded during 6 pre-intervention months were used to determine the rate of CLABSI during the 6-month pre-intervention period.	Number of CLABSI infections and CVC/day recorded during prospective period were used to determine the rate of CLABSI during the 6-month post-intervention period.
Measure Participants	NA	NA
Measure ICU and non-ICU wards	36	36
Number [CLABSI rate per 1000 catheter days]	2.9	3.2

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Infections from patients with indwelling urinary catheters in one ICU ward. Total 6 units. No individual patients were enrolled in this study. No patients assessed for this measure.

Arm/Group Title	CAUTI Rate 6 Months Pre-intervention	CAUTI Rate 6 Months Post-intervention
Arm/Group Description	CAUTI rate per 1000 catheter/days during 6 months pre-intervention	CAUTI rate per 1000 catheter/days during 6 months post intervention
Measure Participants	NA	NA
Measure Units in ICU ward	6	6
Number [CAUTI rate per 1000 catheter days]	0.78	2.26

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Infections from patients who have been intubated and received mechanical ventilation in one ICU ward (6 units). No Patients assessed for this measure.

Arm/Group Title	VAP Rate Pre-intervention	VAP Rate Post Intervention
Arm/Group Description	VAP rate per 1000 ventilator days 6 months pre-intervention	VAP rate per 1000 ventilator days 6 months post-intervention
Measure Participants	NA	NA
Measure Units in ICU ward	6	6
Number [VAP rate per 1000 ventilator days]	6.2	5.35

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who require needleless connectors for CVC IV access or dialysis catheters in one ICU (6 units) and five non-ICU (6 units of each) wards. Total 36 units. No individual patients were enrolled in this study. No Patients assessed for this measure.

Arm/Group Title	MBI-related CLABSI Rate for Pre-intervention Period	MBI-related CLABSI Rate for Prospective Period
Arm/Group Description	Number of MBI CLABSI infections and CVC/day recorded during 6 months of pre-intervention were used to determine the rate of MBI CLABSI during the pre-intervention period.	Number of MBI CLABSI infections and CVC/day recorded during 6 months of prospective period were used to determine the rate of MBI CLABSI during the prospective period.
Measure Participants	NA	NA
Measure ICU and non-ICU wards	36	36
Number [MBI CLABSI rate per 1000 catheter days]	1	1.28

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients who require needleless connectors for CVC IV access or dialysis catheters in one ICU (6 units) and five non-ICU (6 units of each) wards. Total 36 units. No individual patients were enrolled in this study. No Patients assessed for this measure.

Arm/Group Title	Non-MBI CLABSI Rate for Pre-intervention Period	Non-MBI CLABSI Rate for Prospective Period
Arm/Group Description	Number of Non-MBI CLABSI infections and CVC/day recorded during 6 months of pre-intervention were used to determine the rate of CLABSI during the pre-intervention period	Number of Non-MBI CLABSI infections and CVC/day recorded during 6 months of prospective period were used to determine the rate of CLABSI during the prospective period.
Measure Participants	NA	NA
Measure ICU and non-ICU wards	36	36
Number [CLABSI rate per 1000 catheter days]	1.93	1.92

Adverse Events

Time Frame	No individual patient data (including adverse events [AEs]) were recorded during this study.
Adverse Event Reporting Description	No individual patient data (including adverse events [AEs]) were recorded during this study as no individual patient was enrolled into the study .
Arm/Group Title
Arm/Group Description	No individual patient data (including adverse events [AEs]) were recorded during this study.
All Cause Mortality
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

The rate of CLABSI per 1000 central line days was determined by using aggregated data on infections and on CVC/day during the study period. Infections from patients without CVC IV access were also part of the aggregated data recorded. However, as these patients did not have CVC access, they did not contribute to the CVC/day data collected throughout the study. As a result, the rate of CLABSI may have been overestimated.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.