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

Phase 3

Completed

• Conditions: Healthy
• Interventions: Drug: Chlorhexidine gluconate; Drug: Povidone iodine

• Registration Number: NCT00692484
• Lead Sponsor: CareFusion

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Disposition First Submitted: 2013-02-19
• Disposition First Submitted QC: 2013-02-19
• Disposition First Posted: 2013-02-22
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Chlorhexidine gluconate	Chlorhexidine gluconate 2%
2	Povidone iodine	Povidone iodine scrub and paint

Primary Outcome Measures

Name	Time	Method
3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites	10 minutes and 6 hours after application of test solutions

Secondary Outcome Measures

Name	Time	Method
Impact of blotting versus not blotting	Blotting and not blotting after 2 minute application with CHG and 5 minute application of iodophor

Trial Locations

Locations (1)

BioScience Laboratories; 🇺🇸 Bozeman, Montana, United States