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Pilot study to evaluate and compare activity of investigational preoperative preparation (2% CHG) with comparator (2% CHG).
Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using the Tentative Final Monograph (TFM) criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2% CHG 1 min | Experimental | single administration, 1 min application time |
|
| 2% CHG 2 min | Experimental | single administration, 2 min application time |
|
| 2% CHG 3 min | Experimental | single administration, 3 min application time |
|
| Comparator 2% CHG | Active Comparator | Single administration, 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 Abdomen and Groin Sites | Evaluate the Log Reduction of Normal Flora at various sites and timepoints | 10 min, 6 hr and 8 hr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bashir M Hamid, MD | Microbac Laboratories | Principal Investigator |
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Participants were randomized to be treated with at least 2 treatments/Arms (out of 4) at the same time for both groin and abdomen. Numbers represent the total sites tested.
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 | 1 min application time CHG: Varied application times |
| FG001 | CHG 1 Min Groin | 1 min application time CHG: Varied application times |
| FG002 | CHG 2 Min Abdomen | 2 min application time CHG: Varied application times |
| FG003 | CHG 2 Min Groin | 2 min application time CHG: Varied application times |
| FG004 | CHG 3 Min Abdomen | 3 min application time |
| FG005 | CHG 3 Min Groin | 3 min application time |
| FG006 | Comparator CHG Abdomen | Marketed CHG - only applied per products instructions for use |
| FG007 | Comparator CHG Groin | Marketed CHG - only applied per products instructions for use |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Number of participants screened
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| ID | Title | Description |
|---|---|---|
| BG000 | CHG 1, CHG 2, CHG 3, Comparator CHG | Participants could receive up to 2 different treatments at the same time. Treatments included CHG at 1 min, CHG at 2 min, CHG at 3 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, 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 Reduction of Bacterial Flora on Abdomen and Groin Sites | Evaluate the Log Reduction of Normal Flora at various sites and timepoints | The data represents the number of sites (abdomen/groin) tested. | Posted | Log Mean | Standard Deviation | Log 10 Reduction | 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 1 Min | 1 min application time | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. MH Bashir | MicroBioTest | 7039250100 | muhammad.bashir@microbac.com |
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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 |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
2 min application time.
| OG003 | CHG 2 Min Groin | 2 min application time |
| OG004 | CHG 3 Min Abdomen | 3 minute application time |
| OG005 | CHG 3 Min Groin | 3 minute application time |
| OG006 | Comparator CHG Abdomen | Comparator CHG solution |
| OG007 | Comparator CHG Groin | Comparator CHG solution |
|
|
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | CHG 2 Min | 2 min application time | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | CHG 3 Min | 3 minute application time | 0 | 13 | 0 | 13 | 0 | 13 |
| EG003 | Comparator CHG | Instructions for use | 0 | 14 | 0 | 14 | 0 | 14 |
Data remains confidential