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This study evaluates the use of 2% CHG washcloths in an outpatient setting for adults after hematopoietic stem cell transplant in prevention of central line associated blood stream infections. Half of the participants will use 2% CHG washcloths and other half will use placebo washcloths.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine Gluconate 2% Wipe | Active Comparator |
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| Placebo wipe | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine Gluconate 2% Wipe | Drug |
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| Placebo Wipe |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Primary Blood Stream Infections | Blood stream infections are defined by the presence of bacteria in the blood | 14 weeks |
| Number of Participants With Clinical (Culture-negative) Sepsis | Clinical (culture-negative) sepsis is defined by the presence of low blood pressure without bacteria in the blood | 14 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chlorhexidine Gluconate 2% Wipe | Chlorhexidine Gluconate 2% Wipe |
| FG001 | Placebo Wipe | Placebo Wipe |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2016 |
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| Drug |
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| COMPLETED | Dropout due to fatigue at using wipes was high; compliance is enhanced with monitoring in hospital. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Chlorhexidine Gluconate 2% Wipe | Chlorhexidine Gluconate 2% Wipe |
| BG001 | Placebo Wipe | Placebo Wipe |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Number of Participants With Primary Blood Stream Infections | Blood stream infections are defined by the presence of bacteria in the blood | Among all subjects enrolled. | Posted | Count of Participants | Participants | 14 weeks |
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| Primary | Number of Participants With Clinical (Culture-negative) Sepsis | Clinical (culture-negative) sepsis is defined by the presence of low blood pressure without bacteria in the blood | Among all subjects enrolled. | Posted | Count of Participants | Participants | 14 weeks |
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14 weeks
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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 | Chlorhexidine Gluconate 2% Wipe | Chlorhexidine Gluconate 2% Wipe | 0 | 21 | 0 | 21 | 2 | 21 |
| EG001 | Placebo Wipe | Placebo Wipe | 0 | 29 | 0 | 29 | 1 | 29 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randee Estes, Study Coordinator | University of Chicago | 773-702-1209 | restes@medicine.bsd.uchicago.edu |
| Nov 15, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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