Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation

Study Overview
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Brief Summary
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Objective of this study is to compare the antimicrobial properties of an investigational agent to an active control and a negative control when applied to specific body locations. Testing will be performed according to the procedures outlined in the Food and Drug Administration Tentative Final Monograph (TFM) for Effectiveness Testing of a Patient Preoperative Skin Preparation

Official Title
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Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation

Conditions
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Preoperative Skin Preparation

Intervention / Treatment
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* Drug: OCT - clear
* Drug: OCT- tinted
* Other: ChloraPrep
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects may be of either sex, at least 18 years of age and of any race. Subjects must be in good general health. Subjects must read and sign an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and the List of Restricted Products prior to participating in the study. Female subjects must complete a urine pregnancy test and have negative results documented before proceeding to treatment with test materials. All subjects must meet Screening Day microbial baseline requirements established by the sponsor. Exclusion Criteria: Known allergies or sensitivities to sunscreens, deodorants, laundry detergents, fragrances, vinyl, latex (rubber), alcohols, soaps, metals, inks, dyes, tape adhesives, or to common antibacterial agents found in soaps, lotions, ointments, or particularly the active ingredients of the study product drug solutions. Exposure of test sites to strong detergents, solvents, or other irritants within the 14-day product-restriction period or during the test period. 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 14-day product-restriction period or during the test period. Wear fabric softener-, bug repellent-, or UV-treated clothing during the 14-day product-restriction period or during the test period. Use of systemic or topical antibiotic medications, steroid medications (other than for hormonal contraception or post-menopausal reasons), or any other product known to affect the normal microbial flora of the skin during the 14-day product-restriction period or during the test period. A medical diagnosis of a physical condition, such as a current or recent severe illness, mitral valve prolapse with a heart murmur, congenital heart disease, hepatitis B, hepatitis C, an organ transplant, ports, or an immunocompromised condition such as AIDS (or HIV positive), lupus, medicated diabetes (Type 1 or 2), ulcerative colitis, Crohn's disease, asthma requiring daily medication, fibromyalgia or multiple sclerosis (medicated). Any tattoos or scars within 2 inches of the test sites; skin blemishes or warts may be permissible with the specific approval of the Principal Investigator or consulting physician. Dermatoses, cuts, lesions, active skin rashes, scabs, breaks in the skin or other skin disorders within 6 inches, on, or around the test sites. A currently active skin disease or inflammatory skin condition (for example, contact dermatitis, psoriasis, eczema) anywhere on the body that, in the opinion of the Principal Investigator, would compromise subject safety or study integrity. Subjects who receive an irritation score of 1 (any redness, swelling, rash, or dryness present in any treatment area) for any individual skin condition prior to the Screening Day baseline or Treatment Day baseline sample collection. Participation in another clinical study in the past 30 days or current participation in another clinical study at time of signing informed consent. Showering, bathing, or swimming within the 72 hour period prior to sampling for baseline screening, the test day, or throughout the test period. Pregnancy, plans to become pregnant or impregnate a sexual partner within the pre-test and test periods of the study, or nursing a child. All female subjects will be required to complete a urine pregnancy test on the day of test material application, prior to treatment. Both gender of subjects must be willing to use an acceptable method of contraception to prevent pregnancy for at least 14 days immediately preceding Treatment Day and throughout the duration of the study. Any medical condition or use of any medications that, in the opinion of the Principal Investigator or Consulting Physician, would preclude participation. Unwillingness to fulfill the performance requirements of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Product #1 (IP1)<br>octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear | Drug: OCT - clear<br>* Investigational Product #1: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear<br>|
| Experimental: Investigational Product #2 (IP2)<br>octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted | Drug: OCT- tinted<br>* Investigational product #2: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted<br>|
| Active Comparator: Active Control<br>ChloraPrep® - Hi-Lite Orange® applicator | Other: ChloraPrep<br>* Active Control: ChloraPrep® - Hi-Lite Orange® applicator<br>|
| Placebo Comparator: Negative Control<br>sterile 0.9% saline applied with single use applicator | Other: Saline<br>* Negative Control: sterile 0.9% saline applied with single use applicator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antimicrobial Activity of the Investigational Products Compared to Control. |  | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Rate at 6 Hours Post-application | Number of participants with bacterial reduction greater than or equal to baseline (0) | 6 hours |