Pilot Evaluation of the Application Procedure on the Antimicrobial Effects of 2 Antiseptics - Full Text View

Sponsored by:	Enturia
Information provided by:	Enturia
ClinicalTrials.gov Identifier:	NCT00692484

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Chlorhexidine gluconate Drug: Povidone iodine	Phase III

Drug Information available for: Iodine Cadexomer iodine Chlorhexidine Chlorhexidine digluconate Povidone-iodine Povidone D-Gluconic acid, monosodium salt Gluconic acid Manganese gluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pilot Evaluation of the Effect of Application Procedure on the Antimicrobial Effects of an Aqueous CHG and a Traditional Iodophor Scrub Paint

Further study details as provided by Enturia:

Primary Outcome Measures:

3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites [ Time Frame: 10 minutes and 6 hours after application of test solutions ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Impact of blotting versus not blotting [ Time Frame: Blotting and not blotting after 2 minute application with CHG and 5 minute application of iodophor ] [ Designated as safety issue: No ]

Enrollment:	25
Study Start Date:	October 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Chlorhexidine gluconate 2%	Drug: Chlorhexidine gluconate Chlorhexidine gluconate (2% w/v) in an aqueous base. Administered topically.
2: Active Comparator Povidone iodine scrub and paint	Drug: Povidone iodine Povidone iodine scrub and paint. Administer topically.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692484

Locations

United States, Montana
BioScience Laboratories
Bozeman, Montana, United States, 59715

Sponsors and Collaborators

Enturia

Investigators

Principal Investigator:

Daryl S Paulsen, PhD

President and CEO

More Information

Responsible Party:	Enturia, Inc. ( Cynthia Crosby, Vice President, Medical Affairs )
Study ID Numbers:	060629
Study First Received:	June 4, 2008
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00692484
Health Authority:	United States: Food and Drug Administration

Keywords provided by Enturia:

Antimicrobial
Antisepsis
Topical antisepsis

Study placed in the following topic categories:

Chlorhexidine
Chlorhexidine gluconate
Povidone

Iodine
Povidone-Iodine
Healthy

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
Therapeutic Uses
Hematologic Agents

Blood Substitutes
Plasma Substitutes
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009