Pilot Evaluation of the Application Procedure on the Antimicrobial Effects of 2 Antiseptics

C. R. Bard

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Drug: Chlorhexidine gluconate; Drug: Povidone iodine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00692484

060629

Details and patient eligibility

About

Evaluate effect of application procedure on efficacy of 2 antiseptics for cleaning skin prior to surgery.

Full description

Evaluate the effect of application procedure on the antimicrobial properties of a new product and a currently marketed product. Study will be conducted using methods dictated by the FDA.

Study uses topical sampling from the abdomen and groin on intact skin and evaluates the germs. Effects of blotting versus not blotting will be assessed.

Enrollment: 122 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Free of dermatoses, cuts, lesions, or other skin disorders around test sites
• must not have received topical or systemic antimicrobials, antibiotics, or steroids for 7 days prior to testing and agree to abstain from these materials until completion of the study

Exclusion criteria

• Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the 7 day pre-test period or during the test period
• exposure of the test sites to strong detergents, solvents, or other irritants during the 7 day pre-test period or during the test period
• use of systemic or topical antibiotic medications, steroid medications, or any other product known to affect the normal microbial flora of the skin during the 7 day pre-test period or during the test period
• known allergy to latex (rubber), alcohols, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate and povidone iodine
• active skin rashes or breaks in the skin of the test sites
• currently active skin disease or inflammatory skin condition, including contact dermatitis
• showering or bathing within the 72 hour period prior to sampling
• participation in a clinical study in the past 7 days or current participation in another clinical study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

1

Experimental group

Description:

Chlorhexidine gluconate 2%

Treatment:

Drug: Chlorhexidine gluconate

2

Active Comparator group

Description:

Povidone iodine scrub and paint

Treatment:

Drug: Povidone iodine