Passive Disinfection Cap Compliance Study

NCT03391960 | Completed Results FDA Device

• 2 other identifiers: CLIN-PROT-ICH-US-05-319980Study 05-014137
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection, Hospital

Keywords

CLABSI; Septicemia; Bloodstream infection; Central line associated bloodstream infection; Catheter related bloodstream infection; Intravascular device; Catheter port

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• CLABSI Rate

  6-month retrospective period and 6-month prospective period

• Catheter-associated Urinary Tract Infection (CAUTI) Rate

  6 months pre-intervention and 6 months post intervention

• Ventilator-associated Pneumonia (VAP) Rate

  6-month retrospective period and 6-month prospective period

• MBI-Related CLABSI Rate

  6-month retrospective period and 6-month prospective period

• Non MBI-related CLABSI Rate

  6-month retrospective period and 6-month prospective period

Study Arms (1)

Disinfecting barrier cap

OTHER

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

Interventions

Passive disinfection device DEVICE

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

Also known as: Passive disinfecting cap, Disinfecting cap, Curos disinfecting cap, Curos cap

Disinfecting barrier cap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Solventum US LLC: lead
• Eurotrials Brasil Consultores Cientificos Ltda: collaborator
• 3M: collaborator

Study Sites (1)

3M HealthCare

Maplewood, Minnesota, 55144, United States

Location

MeSH Terms

Conditions

Cross Infection; Sepsis

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Inflammation

Limitations and 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.

Results Point of Contact

• Title: Helen Han
• Organization: 3M

mhan3@mmm.com

651-737-9234

Study Officials

• Ricardo A Zimerman, MD

  Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: January 5, 2018
• Study Start: April 1, 2018
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: October 2, 2024
• Results First Posted: February 9, 2022

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)