Evaluating Safety and Effectiveness of Octenidine Dihydrochloride

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of a topical antiseptic for preoperative skin preparation

Official Title
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A RANDOMIZED, SINGLE-CENTER, BLINDED, PILOT CLINICAL EVALUATION OF THE ANTIMICROBIAL EFFECTIVENESS OF THERMALLY TREATED CLOTHS IMPREGNATED WITH 0.4% OCTENIDINE DIHYDROCHLORIDE AQUEOUS SOLUTION COMPARED TO THERMALLY TREATED CLOTHS IMPREGNATED WITH VEHICLE FORMULATION AND TO SAGE 2% CHLORHEXIDINE GLUCONATE CLOTH FOR PREOPERATIVE SKIN PREPARATION

Conditions
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Preoperative Skin Preparation

Intervention / Treatment
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* Drug: Chlorhexidine gluconate
* Drug: N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride
* Drug: Placebo


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 List of Restricted Products prior to participating in the study. Female subjects must have a negative urine pregnancy test documented before treatment with test materials. Screening day microbial baseline meeting minimum skin flora baseline requirements on abdomen and groin. Exclusion Criteria: Known allergies or sensitivities to sunscreens, deodorants, laundry detergents, fragrances, vinyl, latex (rubber), alcohols, metals, inks, or to common antibacterial agents found in soaps, lotions, or ointments. 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-treated clothing (including bug-repellent and 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, or an immunocompromised condition such as AIDS (or HIV positive), lupus, diabetes, Crohn's disease, asthma or medicated multiple sclerosis. 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 at 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. 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: comparator<br>Chlorhexidine gluconate | Drug: Chlorhexidine gluconate<br> <br> |
| Experimental: experimental<br>BDIP-0001 | Drug: N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride<br> <br> |
| Placebo Comparator: placebo<br>Vehicle | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Abdominal Site Responder Rates at 10 Minutes | Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a 2 log10/cm^2 CFU reduction were considered responders, and individually treated groin sites with a 3 log10/cm^2 CFU reduction were considered responders. | 10 min | 
| Percentage of Abdominal Site Responder Rates at 6 Hours | Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a log10/cm^2 CFU reduction greater than or equal to 0 were considered responders. | 6 hours | 
| Percentage of Groin Site Responder Rate at 6 Hours | Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a log10/cm^2 CFU reduction greater than or equal to 0 were considered responders. | 6 hours | 
| Percentage of Groin Sites Responder Rates at 10 Minutes | Participants were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a 3 log10/cm^2 CFU reduction were considered responders. | 10 minutes |