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Pilot study to evaluate and compare activity of preoperative preparation with comparator
Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using TFM criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHG 1 min | Experimental | 1 min application time |
|
| CHG 2 min | Experimental | 2 min application time |
|
| Comparator CHG | Active Comparator | Marketed CHG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHG | Drug | Varied application times |
|
| Measure | Description | Time Frame |
|---|---|---|
| Log Reduction of Bacterial Flora on the Abdomen and Groin | Evaluate the Log Reduction of normal flora at various timepoints. | 10 min, 6 hr and 8 hr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Campbell | Bioscience Labs | Principal Investigator |
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Data to be shared with FDA
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Participants were randomized to be treated with at least 2 treatments/ Arms (out of 3) at the same time for both groin and abdomen. Total numbers represent sites not the individual number of participants.
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 qualifications.
| ID | Title | Description |
|---|---|---|
| FG000 | CHG 1 Min Abdomen | CHG 1 min Abdomen sites |
| FG001 | CHG 2 Min Abdomen | CHG 2 min Abdomen sites |
| FG002 | Comparator CHG Abdomen | Marketed CHG - only applied per products instructions for use |
| FG003 | CHG 1 Min Groin | CHG 1 min Groin sites |
| FG004 | CHG 2 Min Groin | CHG 2 min Groin sites |
| FG005 | Comparator CHG Groin | Marketed CHG - only applied per products instructions for use |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants received up to 2 treatments at the same time. The treatments included 2 different testing sites.
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| ID | Title | Description |
|---|---|---|
| BG000 | CHG 1, CHG 2, Comparator CHG | Participants could receive up to 2 different treatments at the same time. Treatments included CHG at 1 min, CHG at 2 min or Comparator CHG. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 Reduction of Bacterial Flora on the Abdomen and Groin | Evaluate the Log Reduction of normal flora at various timepoints. | Determine 70% responder rates | Posted | Mean | Standard Deviation | Log10 Reductions | 10 min, 6 hr and 8 hr | Sites Exposed | Sites Exposed |
|
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 1 Min, CHG 2 Min, Comparator CHG | 1 min application time, 2 min application time or comparator application. Up to 2 products applied to the same participant. |
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Small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| C. Beausoleil | BSL | 406-587-5735 | cbeausoleil@biosciencelabs.com |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
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| years |
|
| Sex: Female, Male | 33 participants were evaluated with up to 2 products. However only participants that achieved baseline criteria based on post testing analysis were used in the final analysis. The total of participants used was 21. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Sites exposed |
|
Marketed CHG Standard Application Time
| OG003 | CHG 1 Min Groin | 1 min application time |
| OG004 | CHG 2 Min Groin | 2 min application time |
| OG005 | Comparator CHG Groin | Comparator CHG Standard Application Time |
|
|
| 0 |
| 33 |
| 0 |
| 33 |
Data considered confidential