Pilot Evaluation of the Application Procedure on the Antimicrobial Effects of 2 Antiseptics (NCT00692484) | Clinical Trial Compass
CompletedPhase 3
Pilot Evaluation of the Application Procedure on the Antimicrobial Effects of 2 Antiseptics
United States122 participantsStarted 2007-10
Plain-language summary
Evaluate effect of application procedure on efficacy of 2 antiseptics for cleaning skin prior to surgery.
Who can participate
Age range18 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites
Timeframe: 10 minutes and 6 hours after application of test solutions