Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-04 @ 8:54 AM
Study NCT ID:
NCT03391960
Status:
COMPLETED
Last Update Posted:
2024-10-02
First Post:
2017-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Passive Disinfection Cap Compliance Study
Sponsor:
Solventum US LLC
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Study 05-014137 | OTHER | 3M | View |