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CHG 2% w/v & IPA 70% v/v, swabstick · 1 trial · 1 indication
The bacterial reductions achieved by the test products and the controls using 2 different application techniques at 10-minute and 6-hour sampling intervals for both groin and abdominal sites were evaluated.
| Arm | Type | Description |
|---|---|---|
| CHG Swabstick (3 @ once) | EXPERIMENTAL | Chlorhexidine gluconate (CHG) 2% w/v CHG/isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied @ same time |
| CHG Swabstick sequential | EXPERIMENTAL | Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied sequentially |
| Hibiclens | ACTIVE_COMPARATOR | Chlorhexidine gluconate (CHG) 4% w/v in an aqueous base |
| Sterile water swab (3 @ once) | PLACEBO_COMPARATOR | Sterile swabstick wetted with sterile deionized water - 3 swabsticks applied at the same time. |
| Sterile water swabstick (sequential) | PLACEBO_COMPARATOR | Sterile swabstick wetted with sterile water--3 swabsticks applied sequentially. |
| Name | Type | Description |
|---|---|---|
| CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once). | DRUG | 3 swabsticks topically applied at the same time to intact skin |
| CHG 2% w/v & IPA 70% v/v swab applied sequentially | DRUG | Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin. |
| Aqueous CHG 4% w/v applied according to mfr's directions | DRUG | Chlorhexidine gluconate 4% w/v in an aqueous base applied according to mfr's directions. Step 1) 5 ml of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated. |
| Sterile swabstick with sterile water (3 @ once) | OTHER | 3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time. |
| Sterile swabstick with sterile water (one-at-a-time) | OTHER | Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time. |
Inclusion Criteria: * Subjects must read and sign an Informed Consent Form and be cooperative. * Subjects must be in good general health. * Subjects must have skin within 6 inches of the test site that is free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorders. Exclusion Cri...
CHG 2% w/v & IPA 70% v/v, swabstick is an investigational topical antiseptic product combining chlorhexidine gluconate and isopropyl alcohol in a swabstick applicator. It is being developed by Becton, Dickinson and Company for topical antisepsis, the reduction of microorganisms on skin before procedures such as surgery.
CHG 2% w/v & IPA 70% v/v, swabstick is being studied for topical antisepsis, including preoperative skin preparation. A completed Phase 3 trial evaluated it for preoperative skin preparation in healthy volunteers aged 16 years and older in the United States.
Becton, Dickinson and Company, which trades under the ticker BDX, is the developer of CHG 2% w/v & IPA 70% v/v, swabstick. The company is studying the product for topical antisepsis.
CHG 2% w/v & IPA 70% v/v, swabstick has completed a Phase 3 clinical trial and remains an investigational product. It is not described as approved, and no active trials are currently listed for it.
CHG 2% w/v & IPA 70% v/v, swabstick was evaluated in one completed Phase 3 trial, NCT00799812, titled Test for Pre Operative Skin Preparations. The trial enrolled 335 participants in the United States, was randomized and placebo-controlled, and included healthy volunteers aged 16 years and older.