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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 used for topical antisepsis, specifically as a preoperative skin preparation. It is a small molecule product being developed by Becton, Dickinson and Company (BDX) for application to the skin to reduce microorganisms before surgical procedures.
CHG 2% w/v & IPA 70% v/v, swabstick contains chlorhexidine gluconate (CHG) and isopropyl alcohol (IPA) as its active ingredients. CHG is an antiseptic that disrupts microbial cell membranes, while IPA denatures proteins, providing broad-spectrum antimicrobial activity for skin antisepsis.
CHG 2% w/v & IPA 70% v/v, swabstick is developed by Becton, Dickinson and Company, a medical technology company traded on the New York Stock Exchange under the ticker BDX. The product is being studied for use in topical antisepsis.
CHG 2% w/v & IPA 70% v/v, swabstick is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. One Phase 3 trial has been completed to evaluate its safety and efficacy for preoperative skin preparation.
CHG 2% w/v & IPA 70% v/v, swabstick has one completed Phase 3 clinical trial, NCT00799812, titled 'Test for Pre Operative Skin Preparations.' This randomized, placebo-controlled study enrolled 335 participants in the United States, including healthy volunteers aged 16 years and older, to evaluate the product for topical antisepsis.