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Evaluate the effects of CHG cloth on the reduction of bacteria on the skin.
Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin area 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 | comparison with other CHG products |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | Percent of abdomen and groin sites that achieve a 2-Log or 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 on the abdomen and groin at baseline. | 10 minutes to 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| C Beausoleil | BS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioScience | Butte | Montana | 59701 | 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 | marketed CHG - application done per products instructions for use |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abdomen |
|
| ||||||||||||||||||
| Groin |
|
The Overall Number of Baseline Participants represents the total number of participants that qualified and were tested.
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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 Sites | Percent of abdomen and groin sites that achieve a 2-Log or 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 on the abdomen and groin at baseline. | Participants received 1 or 2 products on up to 2 abdomen and 2 groin sites, 2 abdomen only sites or 2 groin sites only. | Posted | Number | % of Treated Sites | 10 minutes to 8 hours | sites | sites |
|
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Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
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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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| C Beausoleil | Bioscience Labs | 460-782-5498 | cbeausoleil@biosciencelabs.com |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| D002864 | Chromogranins |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
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| Vehicle | Other | Excipients of CHG product only. |
|
|
| DynaHex-2 | Drug | 2% CHG solution |
|
|
| NOT COMPLETED |
|
|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
single application on groin.
| OG002 | Vehicle Abdomen | single application on abdomen |
| OG003 | Vehicle Groin | single application on groin |
| OG004 | Comparator Abdomen | single application on abdomen |
| OG005 | Comparator Groin | single application of groin |
|
|
| 0 |
| 755 |
| 16 |
| 755 |
| EG001 | Vehicle | Excipients of CHG product only. | 0 | 136 | 4 | 136 |
| EG002 | Comparator CHG | 2% CHG solution | 0 | 753 | 8 | 753 |
| Irritation skin | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Skin Abrasion | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
Confidential information based on contract
| D004364 |
| Pharmaceutical Preparations |