Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Chlorhexidine Gluconate
CHG · 6 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.
Change was calculated as the baseline time point minus the later time points over an 8 hour period.
Evaluate the Log Reduction of Normal Flora at various sites and timepoints
| 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 | - |
| CHG Cloth | EXPERIMENTAL | 3 min application time |
| Comparator CHG | ACTIVE_COMPARATOR | Marketed 2% CHG |
| 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 |
|---|---|---|
| Chlorhexidine gluconate | DRUG | 2% CHG solution on cloth |
| DynaHex-2 | DRUG | 2% CHG solution |
| Vehicle | OTHER | Excipients of CHG product only |
| CHG | DRUG | Single application |
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
CHG, or chlorhexidine gluconate, is being studied as a preoperative skin preparation for surgery. The two Phase 1 pilot trials listed for CHG enrolled healthy volunteers to evaluate its use in preparing skin before surgical procedures. Both trials have been completed.
CHG is developed by Medline Inc., which trades under the ticker MDLN. Medline is the sponsor associated with the CHG preoperative skin preparation program, which includes two completed Phase 1 pilot trials in surgical settings.
CHG is in Phase 1 development. Both trials of CHG are Phase 1 pilot studies, and both are completed, with no active trials currently listed. The program enrolled a total of 41 participants across the two studies.
CHG has been studied in two completed Phase 1 trials: NCT02530554, a pilot trial of chlorhexidine gluconate preoperative skin preparation that enrolled 14 participants, and NCT02530528, a pilot trial of preoperative chlorhexidine gluconate skin preparation that enrolled 27 participants. Both were active-controlled and randomized.
Yes, CHG is the abbreviation for chlorhexidine gluconate. The two Phase 1 pilot trials of CHG are titled as studies of chlorhexidine gluconate preoperative skin preparation, so the names refer to the same small molecule being developed by Medline Inc. for surgical use.
CHG has been evaluated in two completed Phase 1 pilot trials in surgery. Both were randomized and active-controlled, enrolled healthy volunteers, and were open-label rather than double-blind. Enrollment was 14 participants in NCT02530554 and 27 participants in NCT02530528, for a total of 41.