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Medline 2% CHG cloth (Active) - A single cloth from the pack was used per treatment area. The investigational test article was applied topically by vigorously scrubbing the skin in a back and forth motion for three minutes (and halfway through the 3-minute application time, the cloth was turned over) over the treatment area (7" x 10" of the subject's back), and the skin was allowed to air dry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine Gluconate | Experimental | 2% CHG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% CHG | Drug | Chlorhexidine Gluconate |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Medline 2% CHG Cloth Dosage of Coverage Area | To measure the dosage of the coverage area of a single investigational test article, Medline 2% CHG cloth calculated in grams per square centimeter | 3 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Post-application Drying Time | To assess post-application drying time after a single dose topical application of Medline 2% CHG cloth. Drying time is defined as when the entire treatment area appears visibly dry. | Approximately 1 minute |
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Inclusion Criteria:
Healthy males of at least 18 years of age having skin within 6 inches of the test regions that were free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders, with no history of sensitivity to CHG and were able to lie prone for up to 30 minutes.
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| Name | Affiliation | Role |
|---|---|---|
| Hamid Bashir | Microbac Laboratories, Inc. | Principal Investigator |
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Healthy males at least 18 years of age having skin within 6 inches of the test regions that were free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders, with no histroy of sensitivity to CHG and able to lie prone for up to 30 minutes.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2% CHG Cloth | 2% chlorhexidine gluconate cloth |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 2% CHG Cloth | 2% chlorhexidine gluconate cloth |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Medline 2% CHG Cloth Dosage of Coverage Area | To measure the dosage of the coverage area of a single investigational test article, Medline 2% CHG cloth calculated in grams per square centimeter | Posted | Mean | Standard Deviation | g/cm^2 | 3 minutes |
|
|
3 days
There were zero adverse events reported throughout the duration of the study.
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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 | 2% CHG Cloth | 2% chlorhexidine gluconate cloth | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Regulatory Affairs Specialist | Medline Industries | 847-643-3515 | aminarcik@medline.com |
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| ID | Term |
|---|---|
| D002864 | Chromogranins |
| ID | Term |
|---|---|
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Post-application Drying Time | To assess post-application drying time after a single dose topical application of Medline 2% CHG cloth. Drying time is defined as when the entire treatment area appears visibly dry. | Posted | Mean | Standard Deviation | seconds | Approximately 1 minute |
|
|
|
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
Data remains confidential