Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02526667 | Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Volunteers | PHASE3 | COMPLETED | 340 | — | — | Aug 1, 2015 | Dec 1, 2015 | Sep 28, 2020 | 1 | Romania |
| NCT02291601 | Preoperative CHG Cloth on Healthy Subjects | PHASE3 | COMPLETED | 879 | — | — | Oct 1, 2014 | Sep 1, 2015 | Apr 30, 2021 | 1 | United States |
| NCT02222896 | Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Subjects | PHASE3 | COMPLETED | 347 | — | — | Aug 1, 2014 | May 1, 2015 | May 21, 2021 | 1 | United States |
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.
| 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 |
| 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