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Healthy volunteers will receive treatment to two body locations with the investigational product and placebo and the antimicrobial effectiveness of each treatment will be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Product | Experimental | Polyester cloth impregnated with investigational product |
|
| Vehicle Control (VC) | Placebo Comparator | Polyester cloth impregnated with the vehicle control |
|
| Saline Control (SC) | Placebo Comparator | Saline applied wtih polyester cloth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octenidine Dihydrocloride in aqueous solution | Drug | application of investigational product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial Count at 10 Minutes Post Application | 10 minutes after application of test product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Beausoleil | BioScience Laboratories | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioScience Laboratories | Bozeman | Montana | 59718 | United States |
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Participants were only treated if baseline bacterial counts met the inclusion criteria.
Participants were treated with 2 of 3 study products (Investigational Product, saline control, vehicle control) 1 on the left side of the body (both groin and abdomen), 1 on the right side of the body (both groin and abdomen). Therefore, treatment groups are not discrete categories.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All screened participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Participants were treated with multiple study products. Therefore, treatment groups are not discrete categories and cannot be displayed by treatment group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Treated | Participants who received study product at at least 1 treatment site (abdomen and/or groin). Participants were treated with 2 of 3 study products, investigational product (IP), saline control (SC), and/or vehicle control (VC). Therefore, treatments arms are not discrete groups of participants. Therefore, baseline data are presented for all treated participants and not by treatment arm. |
| 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 | Bacterial Count at 10 Minutes Post Application | Analysis only includes participants with required treatment day baseline bacterial counts at each anatomical site at baseline and non-missing data at 10 minutes. | Posted | Mean | Standard Deviation | log10 CFU/cm^2 | 10 minutes after application of test product |
|
10 minutes
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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 | Subject Treated | Participants who received study product at at least 1 treatment site (abdomen and/or groin). Participants were treated with 2 of 3 study products, investigational product (IP), saline control (SC), and/or vehicle control (VC). Therefore, treatments arms are not discrete groups of participants. Therefore, adverse event data are presented for all treated participants and not by treatment arm. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Zook | Becton Dickinson | 224-358-5019 | erin.zook@bd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2017 | Dec 2, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 23, 2017 | Dec 2, 2020 | SAP_002.pdf |
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| Vehicle Control | Other | application of vehicle control |
|
| Saline Control | Other | application of placebo |
|
| years |
|
| 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 |
|
| Vehicle Control |
Vehicle Control (VC) Thermally treated polyester cloths impregnated with vehicle formulation. |
|
|
|
| 0 |
| 69 |
| 0 |
| 69 |
| 0 |
| 69 |
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