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Chlorhexidine gluconate · 3 trials · 3 indications
Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a 2 log10/cm\^2 CFU reduction were considered "responders," and individually treated groin sites with a 3 log10/cm\^2 CFU reduction were considered "responders."
Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a log10/cm\^2 CFU reduction greater than or equal to 0 were considered responders.
Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a log10/cm\^2 CFU reduction greater than or equal to 0 were considered responders.
Participants were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a 3 log10/cm\^2 CFU reduction were considered "responders."
| Arm | Type | Description |
|---|---|---|
| CHG 2%-26 ml | EXPERIMENTAL | Chlorhexidine gluconate in an aqueous base, 26 ml applicator |
| ChloraPrep 26 ml | ACTIVE_COMPARATOR | ChloraPrep One-Step 26 ml Active drug contains chlorhexidine gluconate and alcohol |
| Sterile Saline | PLACEBO_COMPARATOR | Sterile salt water administered topically. |
| 1 | EXPERIMENTAL | Chlorhexidine gluconate 2% |
| 2 | ACTIVE_COMPARATOR | Povidone iodine scrub and paint |
| comparator | ACTIVE_COMPARATOR | Chlorhexidine gluconate |
| experimental | EXPERIMENTAL | BDIP-0001 |
| placebo | PLACEBO_COMPARATOR | Vehicle |
| Name | Type | Description |
|---|---|---|
| Chlorhexidine gluconate | DRUG | Chlorhexidine gluconate (2% w/v) in an aqueous base, 26 ml applicator. Active drug contains alcohol and the placebo contains no drug. Administered topically. |
| ChloraPrep One Step | DRUG | Administer topically |
| Sterile saline | DRUG | 0.9% NaCl solution |
| Povidone iodine | DRUG | Povidone iodine scrub and paint. Administer topically. |
| N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Free of dermatoses, cuts, lesions, or other skin disorders on or around the test sites; no exposure to topical or systemic antimicrobials, antibiotics, or steroids (other than contraceptives, for the fourteen (14) day pre-test conditioning period and must agree to abstain from...
Chlorhexidine gluconate is a small molecule used for preoperative skin preparation and topical antisepsis in healthy individuals. It is being developed by Becton, Dickinson and Company (BDX) and is currently in Phase 3 clinical development, though it is still investigational and not yet approved.
Chlorhexidine gluconate is a topical antiseptic that works by disrupting microbial cell membranes, leading to cell death. It is used to reduce bacteria on the skin before surgery or other medical procedures to prevent infection.
Chlorhexidine gluconate is being developed by Becton, Dickinson and Company, a medical technology company traded on the New York Stock Exchange under the ticker BDX.
Chlorhexidine gluconate is in Phase 3 clinical development for preoperative skin preparation and topical antisepsis. It is an investigational drug and has not been approved by regulatory authorities.
Chlorhexidine gluconate has completed three clinical trials. NCT00636480 and NCT00692484 were Phase 3 studies evaluating its antimicrobial effects in healthy volunteers, and NCT03140254 was a Phase 2 study comparing it to octenidine dihydrochloride for preoperative skin preparation.
No, Chlorhexidine gluconate is not the same as octenidine dihydrochloride. They are different antiseptic agents. In one clinical trial (NCT03140254), octenidine dihydrochloride was studied as a comparator against Chlorhexidine gluconate for preoperative skin preparation.