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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 Chlorhexidine Gluconate (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 |
|---|---|---|
| Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | Log10 reduction in bacteria on the skin evaluated at 10 minutes, 6 hours and 8 hours after treatment. Responder rates (%) are the percentage of sites identified that produced a 2-Log and 3-Log reduction from baseline for abdomen and groin sites respectively. | 10 minutes, 6 hours, 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R Olsavcszky, MD | S.C. BIO HIGH TECH S.R.L. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bio High Tech SRL | Bucharest | Romania |
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 to 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 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 | Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | Log10 reduction in bacteria on the skin evaluated at 10 minutes, 6 hours and 8 hours after treatment. Responder rates (%) are the percentage of sites identified that produced a 2-Log and 3-Log reduction from baseline for abdomen and groin sites respectively. | Number of participants involved in the analyses. | Posted | Number | Percent of sites | 10 minutes, 6 hours, 8 hours | Sites | Sites |
|
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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 Abdomen | CHG, 3 min application to abdomen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Olsavszky | Evic Romania | 40 21 335 70 90 | research@evic.ro |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
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| DynaHex-2 | Drug | 2% CHG solution |
|
|
| Vehicle | Other | Excipients of CHG product only |
|
|
| NOT COMPLETED |
|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Vehicle Abdomen | single application on abdomen |
| OG003 | Vehicle Groin | single application on groin |
| OG004 | Comparator CHG Abdomen | single application on abdomen |
| OG005 | Comparator CHG Groin | single application on groin |
|
|
| 0 |
| 284 |
| 0 |
| 284 |
| EG001 | Vehicle Abdomen | Vehicle 3 min application to abdomen | 0 | 56 | 0 | 56 |
| EG002 | Comparator CHG Abdomen | CHG comparator applied to abdomen | 0 | 281 | 0 | 281 |
| EG003 | CHG Cloth Groin | CHG, 3 min application to groin | 0 | 290 | 0 | 290 |
| EG004 | Vehicle Groin | Vehicle 3 min application to groin | 0 | 56 | 0 | 56 |
| EG005 | Comparator CHG Groin | CHG comparator applied to groin | 0 | 294 | 0 | 294 |
Confidential information based on contract.