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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 for topical antisepsis, the reduction of microorganisms on skin before procedures. Becton, Dickinson and Company (BDX) is the developer.
CHG 2% w/v & IPA 70% v/v, swabstick is intended for topical antisepsis, including preoperative skin preparation. The completed Phase 3 trial enrolled healthy volunteers aged 16 years and older to test preoperative skin preparations. It is designed as a single-use swabstick applicator for applying the antiseptic solution to skin.
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 listed as the sponsor of the product's clinical development program in topical antisepsis.
CHG 2% w/v & IPA 70% v/v, swabstick has completed a Phase 3 clinical trial. It is an investigational product and is not approved by the FDA. The Phase 3 study, NCT00799812, is listed as completed, and no active trials are currently recorded for this product.
CHG 2% w/v & IPA 70% v/v, swabstick has been studied 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 of all sexes.