An interventional study of Passive disinfection device in Infection, Hospital, sponsored by Solventum US LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-02.
Sponsored by Solventum US LLC · Not applicable, Interventional, and Other
Among 60 studies in Cross Infection with a site in United States — 5 open to participants now, 6 under way, none of them phase 3. Cross Infection · United States.
Among the 60 studies in Cross Infection with a site in United States, this one is the 21st largest by enrollment of the 40 interventional ones that give a count, is one of 3 that started in 2018, is one of 20 with no phase, and was the 41st registered.
285 studies on the registry are indexed under Cross Infection; 48 are open to participants now.
Browse Cross Infection studies →5 of the 60 studies in Cross Infection with a site in United States are open now. Recruiting first, the newest first:
Swedish Medical Center · Sites in United States
Ages 18+
University of Minnesota · Sites in United States
Ages 18+
University of North Carolina, Chapel Hill · Sites in United States
Ages 1 mo–99 yrs
Oregon Health and Science University · Sites in United States
Ages 18–99
National Institutes of Health Clinical Center (CC) · Sites in United States
Ages 2–120
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 27 Cross Infection studies recruiting now, 22 (81%) set no upper age limit and 3 (11%) stop at 75 or younger; 5 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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60 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 13 · Phase 3 5 · Phase 4 4
First in 2001; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 165 is below the median of 185 across 169 interventional studies indexed under Cross Infection.
Median enrollment 167 across the 40 interventional studies, 525 across the 20 observational. Of the 51 that completed or were terminated, 22 (43%) have results posted.
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9 of 60 have an industry lead sponsor. The 10 most frequent:
Solventum US LLC is the lead sponsor of 64 studies on the registry; 2 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
Solventum US LLC has 1 study filed under Cross Infection — fewer than ten, so there is no comparison to draw.
1 of the studies in Cross Infection with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06378359University of MinnesotaEffectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients | 2026-12-31 |
Among the 60 studies in Cross Infection with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Also known as: Passive disinfecting cap, Disinfecting cap, Curos disinfecting cap, Curos cap
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.
Time frame: 6-month prospective period
Scrub the Hub Protocol Compliance
Compliance with Scrub the hub protocol Data collected retrospectively by survey
Time frame: 6-month retrospective period
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6-month retrospective period and 6-month prospective period
No individual patient was recruited into the study.
| Milestone | Compliance With Scrub the Hub Protocol | Compliance With Disinfecting Barrier Cap Ptotocol |
|---|---|---|
| Started | 165 | NA |
| Completed | 165 | NA |
| Not completed | 0 | NA |
| Withdrew: Protocol violation | 0 | NA |
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.
| percentage of connector with compliance | Disinfecting Barrier Cap Compliance |
|---|---|
| Disinfecting Barrier Cap Compliance | 98.43 ± 4.18 |
Compliance with Scrub the hub protocol Data collected retrospectively by survey
| percentage of protocol compliance | Scrub the Hub Protocol Compliance |
|---|---|
| Scrub the Hub Protocol Compliance | 5.95 ± 21.36 |
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
| CLABSI rate per 1000 catheter days | CLABSI Rate for Pre-intervention Period | CLABSI Rate for Post-intervention Period |
|---|---|---|
| CLABSI Rate | 2.9 | 3.2 |
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.
| CAUTI rate per 1000 catheter days | CAUTI Rate 6 Months Pre-intervention | CAUTI Rate 6 Months Post-intervention |
|---|---|---|
| Catheter-associated Urinary Tract Infection (CAUTI) Rate | 0.78 | 2.26 |
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.
| VAP rate per 1000 ventilator days | VAP Rate Pre-intervention | VAP Rate Post Intervention |
|---|---|---|
| Ventilator-associated Pneumonia (VAP) Rate | 6.2 | 5.35 |
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.
| MBI CLABSI rate per 1000 catheter days | MBI-related CLABSI Rate for Pre-intervention Period | MBI-related CLABSI Rate for Prospective Period |
|---|---|---|
| MBI-Related CLABSI Rate | 1 | 1.28 |
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.
| CLABSI rate per 1000 catheter days | Non-MBI CLABSI Rate for Pre-intervention Period | Non-MBI CLABSI Rate for Prospective Period |
|---|---|---|
| Non MBI-related CLABSI Rate | 1.93 | 1.92 |
Collected over No individual patient data (including adverse events [AEs]) were recorded during this study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group | — | — | — |
Baseline data were not collected for the health care workers. No individual patient was consented in the study.
| Age, Customized | Not Applicable |
|---|
| Sex: Female, Male | Not Applicable |
|---|---|
| Female | — |
| Male | — |
| Race (NIH/OMB) | Not Applicable |
|---|---|
| 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 | Not Applicable |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No individual participant data will be recorded in the study.
Ran from Apr 2018 to primary completion in Oct 2018, 6 months.
Results were first posted in Feb 2022, 3 years 3 months after primary completion.
Of 59 interventional studies with no phase under Cross Infection, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 29. This study's 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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