Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to compare the effectiveness of removal of spores and dirt from the skin using a single cloth bath against a cloth bath with extra rinse step, to establish whether the extra rinse stage will lead to the removal of a higher level of spores and dirt.
The purpose of this study is to evaluate and compare the ability of two test materials to remove Clostridium difficile (ATCC #700057) spores with a tripartite soil load from subjects' forearms. For this study, removal of Clostridium difficile and the associated organic soil load will be used as an indicator of potential removal efficacy for difficult-to-remove microorganisms and associated organic matter from human skin.
All test materials are currently marketed products
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAGE Chlorhexidine Gluconate Cloth | Active Comparator | Ready to use disinfectant cloth |
|
| HUBS with Hibiclens | Active Comparator | Dry cloths to be used with water and disinfectant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine Gluconate | Drug | A cloth to cleanse and disinfect the skin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Removal of Clostridium difficile and the associated organic soil load will be used as an indicator of potential removal efficacy for difficult-to-remove microorganisms and associated organic matter from human skin | As a measure of the ability of the test materials to remove spores from the skin, reductions will be calculated by subtracting the population of spores recovered from a treated sites from the population recovered from the baseline sites. | 2 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Russell Griggs, M.S, CCRC | BSLI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bioscience Laboratories, Inc | Bozeman | Montana | 59718 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
Not provided
Not provided
Not provided
The two study products will be assigned to opposite forearms per a computer-generated randomization schedule. Additionally, the location for baseline and post-product samples will be randomly assigned to the two longitudinally-arranged sites per forearm.
Not provided
Not provided
Not provided
| HUBS with Hibiclens | Combination Product | A dry cloth to be used in combination with water and antimicrobial soap to cleanse and disinfect the skin |
|