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Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on the skin.
Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin areas post CHG application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine Gluconate Cloth | Experimental | 2% CHG, single application |
|
| Vehicle Cloth | Placebo Comparator | Excipients on cloth |
|
| Active Chlorhexidine gluconate solution | Active Comparator | Dynahex 2% CHG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine Gluconate | Drug | 2% CHG solution on cloth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Responder Rates (%) of Bacterial Reduction on the Abdomen and Groin | Percent of abdomen and groin sites that showed response (achieve a 2-Log and 3-Log reduction) respectively of bacterial flora from baseline. Note: the number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels. | 10 minutes, 6 hours, 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H Bashir | MBT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MBT | Sterling | Virginia | 20164 | United States |
Data to be shared with FDA
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The sites of the participant were tested for microbial activity after product application. In some instances, more than one product could have been applied to a participant but only one product per site (groin and/or abdomen sites). Up to 4 sites could be treated: 1)both groin and abdomen, 2) only the groin or 3) only the abdomen.
Upon achieving sufficient microbial growth prior to product application on either the abdomen, groin or both abdomen and groin regions, sites of the participant were then randomized to receive one or two products for evaluation for up 4 sites. Differences in the number of participants is based on microbial qualification.
| ID | Title | Description |
|---|---|---|
| FG000 | CHG Cloth | CHG 3 min application |
| FG001 | Vehicle | Vehicle, 3 min application |
| FG002 | Comparator CHG | CHG Comparator, 3 min application |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abdomen |
|
| ||||||||||||||||||
| Groin |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CHG, Vehicle, Comparator CHG | Single applications of products. 3 min application for CHG and Vehicle. Comparator CHG applied according to instructions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percent Responder Rates (%) of Bacterial Reduction on the Abdomen and Groin | Percent of abdomen and groin sites that showed response (achieve a 2-Log and 3-Log reduction) respectively of bacterial flora from baseline. Note: the number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels. | Participants received product on up to 2 abdomen and 2 groin sites, 2 abdomen only sites or 2 groin sites only. | Posted | Number | Percent of Sites | 10 minutes, 6 hours, 8 hours | Sites | Sites |
|
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The total number of participants that received each product. Some participants could have received up to 2 products at the same time.
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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 | CHG Cloth | Single application |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bashir | Microbac | 703-925-9366 | muhammad.bashir@microbac.com |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
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| Vehicle | Other | Excipients of CHG product only |
|
|
| DynaHex-2 | Drug | 2% CHG solution |
|
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| NOT COMPLETED |
|
|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
CHG 3 min application to groin
| OG002 | Vehicle Abdomen | Vehicle 3 min application to abdomen |
| OG003 | Vehicle Groin | Vehicle 3 min application to groin |
| OG004 | Comparator CHG Abdomen | CHG comparator applied to abdomen |
| OG005 | Comparator CHG Groin | CHG comparator applied to groin |
|
|
| 0 |
| 297 |
| 0 |
| 297 |
| EG001 | Vehicle | Single application | 0 | 59 | 0 | 59 |
| EG002 | Comparative CHG | Single application | 0 | 292 | 0 | 292 |
Confidential information based on contract.