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Pilot study to evaluate and compare activity of CHG preoperative preparation with comparator CHG
Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Efficacy was assess using Tentative Final Monograph (TFM) criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHG Cloth | Experimental | 3 min application time |
|
| Comparator CHG | Active Comparator | Marketed 2% CHG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHG | Drug | Single application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Log Change in Bacterial Flora on Abdomen and Groin | Change was calculated as the baseline time point minus the later time points over an 8 hour period. | 10 min, 6 hr and 8 hr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R Olsavszky, MD | S.C. Bio High Tech S.R.L | Principal Investigator |
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Participants were randomized to be treated with at least 2 treatments/ Arms at the same time for both groin and abdomen. Total numbers represent participants.
Upon achieving sufficient microbial growth prior to product application on either the abdomen and groin regions, sites of the participant were then randomized to received two products for an evaluation or up to 4 sites.
| ID | Title | Description |
|---|---|---|
| FG000 | CHG 3 Min Abdomen | 3 min application time |
| FG001 | CHG 3 Min Groin | 3 min application time |
| FG002 | Comparator CHG Abdomen | Comparator CHG on abdomen sites |
| FG003 | Comparator CHG Groin | Comparator CHG on groin sites |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants would receive up to 2 different treatments at the same time. Treatments included CHG 3 min or comparator CHG.
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| ID | Title | Description |
|---|---|---|
| BG000 | CHG 3 Min, Comparator CHG | CHG applied for 3 min, Comparator CHG applied per 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 | Log Change in Bacterial Flora on Abdomen and Groin | Change was calculated as the baseline time point minus the later time points over an 8 hour period. | Posted | Mean | 95% Confidence Interval | Log (CFU) | 10 min, 6 hr and 8 hr | Sites | Sites |
|
Adverse events were monitored from baseline out to 8 hours.
Participants 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 3 Min and Comparator CHG | 3 min application time for CHG and the comparator CHG was applied according to instructions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. R Olsavszky | Evic Romania | 40 21 335 70 91 | evicromania@evic.ro |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Comparator CHG Groin | CHG Comparator applied to groin |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
Confidential information as part of the contract.