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Label indication Use for the preparation of the patient’s skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
Also known as ChloraPrep AQ
Chlorhexidine gluconate · 2 trials · 2 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. |
| 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 |
| 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 antiseptic being developed by Becton, Dickinson and Company (ticker BDX) for preoperative skin preparation and topical antisepsis. It is designed to reduce microorganisms on the skin before surgical procedures and for general topical antisepsis. The program is in Phase 2 clinical development.
Chlorhexidine gluconate is used for preoperative skin preparation and topical antisepsis. These indications involve reducing skin microorganisms before surgery and for general topical antisepsis. The drug is being developed by Becton, Dickinson and Company for these dermatology applications.
Chlorhexidine gluconate is being developed by Becton, Dickinson and Company, which trades under the ticker BDX. The company is responsible for the clinical development of the drug in preoperative skin preparation and topical antisepsis.
Chlorhexidine gluconate is in Phase 2 clinical development. It is investigational and has not been approved by the FDA for the studied indications. The development program includes a completed Phase 2 trial and a completed Phase 3 trial.
Chlorhexidine gluconate has been studied in two completed clinical trials. NCT03140254 was a Phase 2 trial evaluating safety and effectiveness in preoperative skin preparation, enrolling 145 participants. NCT00636480 was a Phase 3 trial in topical antisepsis, enrolling 60 participants. Both trials were conducted in the United States.