Conditions: Topical Antisepsis
Keywords: antimicrobial antisepsis
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 335
Healthy volunteers: yes

Brief summary:
Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (wetted with sterile deionizd water) applied using the same method as the ChloraPrep Swabstick.

Detailed description:
Determine differences (if any) in 2 different application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens, a liquid antibacterial soap, applied according to the manufacturer's directions as a active/positive comparison. Sterile swabsticks (wetted with sterile deionized water) applied as a negative comparison using the same method as the ChloraPrep swabstick.

Study uses topical sampling from the abdomen and the groin on intact skin and evaluates the germs left on the skin after treatment with ChloraPrep Swabsticks.

Arms:
arm 1: Chlorhexidine gluconate (CHG) 2% w/v CHG/isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied @ same time arm 2: Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied sequentially arm 3: Chlorhexidine gluconate (CHG) 4% w/v in an aqueous base arm 4: Sterile swabstick wetted with sterile deionized water - 3 swabsticks applied at the same time. arm 5: Sterile swabstick wetted with sterile water--3 swabsticks applied sequentially.

Interventions: intervention 1: CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once). intervention 2: CHG 2% w/v & IPA 70% v/v swab applied sequentially intervention 3: Aqueous CHG 4% w/v applied according to mfr's directions intervention 4: Sterile swabstick with sterile water (3 @ once) intervention 5: Sterile swabstick with sterile water (one-at-a-time)
Intervention descriptions: intervention 1: 3 swabsticks topically applied at the same time to intact skin intervention 2: Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin. intervention 3: 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. intervention 4: 3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time. intervention 5: Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time.

Protocol document:
Prot_SAP_000.pdf: