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
Chlorhexidine Gluconate is used for surgical skin preparation before surgery. It is being developed as a preoperative antiseptic cloth to reduce bacteria on the skin prior to surgical procedures. The drug is administered topically and is currently in Phase 3 clinical development for this indication.
Chlorhexidine Gluconate is being developed by Medline Inc., a company publicly traded under the ticker symbol MDLN. Medline is conducting clinical trials to evaluate the drug's effectiveness as a preoperative skin preparation agent in surgical settings.
Chlorhexidine Gluconate is in Phase 3 clinical development for surgical skin preparation. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trials are completed, and the drug is being studied for use before surgery.
Chlorhexidine Gluconate has completed three Phase 3 trials: NCT02222896, NCT02291601, and NCT02526667, all studying preoperative CHG cloths in healthy subjects undergoing surgery. A Phase 1 pharmacokinetic study, NCT03331263, was also completed. All trials are completed with no active trials ongoing.
Yes, Chlorhexidine Gluconate is commonly referred to as CHG. Clinical trial titles use the abbreviation CHG, such as 'Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Subjects.' This antiseptic agent is being evaluated for preoperative skin preparation to reduce surgical site infections.