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| Name | Class |
|---|---|
| Sage Products, Inc. | INDUSTRY |
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The investigators propose to conduct a large clinical study to determine if daily bathing with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated infections in the Pediatric Intensive Care Unit (PICU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Daily bathing with 2% chlorhexidine gluconate |
|
| 2 | No Intervention | Standard bathing with soap and water basin or disposable cloth |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% Chlorhexidine gluconate cloth | Drug | Daily bathing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bacteremia | incidence of bacteremia comparing those in treatment and control groups | participants were followed for the duration of ICU stay, median stay 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Central Line Associated-bloodstream Infection (CLABSI) | Comparing incidence of central line-associated bloodstream infections between treatment and control groups | participants were followed for the duration of ICU stay, median stay 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Bacteremia | per protocol analysis of incidence of bacteremia comparing those in treatment and control groups | duration of ICU stay, median 3 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trish M Perl, MD MSc | Johns Hopkins University | Principal Investigator |
| Aaron Milstone, MD MHS | Johns Hopkins University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Johns Hopkins Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23363666 | Result | Milstone AM, Elward A, Song X, Zerr DM, Orscheln R, Speck K, Obeng D, Reich NG, Coffin SE, Perl TM; Pediatric SCRUB Trial Study Group. Daily chlorhexidine bathing to reduce bacteraemia in critically ill children: a multicentre, cluster-randomised, crossover trial. Lancet. 2013 Mar 30;381(9872):1099-106. doi: 10.1016/S0140-6736(12)61687-0. Epub 2013 Jan 28. |
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5659 enrolled visits in the study, but 712 were excluded from analysis as they did not meet the eligibility criteria
The hospital ICU units underwent a crossover study design, so the ICUs recruited participants in the assigned treatment or control group, then the unit had a washout period, then the unit switched to the alternative assignment of intervention or control for a separate population of participants that were admitted into the ICU.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2% Chlorhexidine Gluconate Cloth | Daily bathing with 2% chlorhexidine gluconate 2% Chlorhexidine gluconate cloth: Daily bathing |
| FG001 | Standard Bath | Standard bathing with soap and water basin or disposable cloth |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (6 Months) |
|
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| Baltimore |
| Maryland |
| 21287 |
| United States |
| Saint Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Per Protocol |
|
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 Washout (2 Weeks) |
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| Period 3 (6 Months) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | Daily bathing with 2% chlorhexidine gluconate 2% Chlorhexidine gluconate cloth: Daily bathing |
| BG001 | Control Arm | Standard bathing with soap and water basin or disposable cloth |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex/Gender, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| PRISM III Score | Severity score that predicts mortality. Range 0 (lowest mortality risk) to 74 (highest mortality risk) | Median | Inter-Quartile Range | score |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bacteremia | incidence of bacteremia comparing those in treatment and control groups | Intent to treat population | Posted | Number | 95% Confidence Interval | events per 1000 at-risk days | participants were followed for the duration of ICU stay, median stay 3 days |
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| ||||||||||||||||||||||||||||
| Secondary | Central Line Associated-bloodstream Infection (CLABSI) | Comparing incidence of central line-associated bloodstream infections between treatment and control groups | Posted | Number | 95% Confidence Interval | events per 1000 at-risk days | participants were followed for the duration of ICU stay, median stay 3 days |
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| Other Pre-specified | Bacteremia | per protocol analysis of incidence of bacteremia comparing those in treatment and control groups | Includes per protocol population of 1547 of 2422 in the treatment arm | Posted | Number | 95% Confidence Interval | events per 1000 at-risk days | duration of ICU stay, median 3 days |
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participants were followed for the duration of ICU stay, median stay 3 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm | Daily bathing with 2% chlorhexidine gluconate 2% Chlorhexidine gluconate cloth: Daily bathing | 0 | 2,422 | 43 | 2,422 | ||
| EG001 | Control Arm | Standard bathing with soap and water basin or disposable cloth | 0 | 2,525 | 26 | 2,525 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aaron Milstone | Johns Hopkins University | 4106143917 | amilsto1@jhmi.edu |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Female |
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| non-Caucasian |
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