Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Chlorhexidine Gluconate · 4 trials · 2 indications
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.
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.
Percent of abdomen and groin sites that showed response (achieve a 2-Log and 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.
A total of 12 blood samples were collected (one tube of 6 mL each) at various time points up before and after product application in each study period and analyzed for plasma levels of chlorhexidine. Blood samples were collected at 10, 2 and 0.5 hours prior to each treatment, and 1, 2, 3, 4, 5, 6, 8, and 12 hours following each treatment.
| Arm | Type | Description |
|---|---|---|
| Chlorhexidine Gluconate Cloth | EXPERIMENTAL | 2% CHG, single application |
| Vehicle Cloth | PLACEBO_COMPARATOR | Excipients on cloth |
| Active Chlorhexidine gluconate solution | ACTIVE_COMPARATOR | Dynahex 2% CHG |
| Abdominal application of 2% CHG | EXPERIMENTAL | - |
| Groin application of 2% CHG | EXPERIMENTAL | - |
| Control treatment with no application | NO_INTERVENTION | - |
| Name | Type | Description |
|---|---|---|
| Chlorhexidine gluconate | DRUG | 2% CHG solution on cloth |
| DynaHex-2 | DRUG | 2% CHG solution |
| Vehicle | OTHER | Excipients of CHG product only |
Inclusion Criteria: * Males or Females * 18 years of age or older * Signed informed consent * Good Health * Six inches of abdomen and groin areas without tattoos, or skin disorders Exclusion Criteria: * Dermatological Conditions * Sensitivity to latex * Sensitivity to CHG