Evaluating Safety and Effectiveness of Octenidine Dihydrochloride

Phase 2

Completed

Conditions: Preoperative Skin Preparation

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

Registration Number: NCT03140254

Lead Sponsor: CareFusion

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 145

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental	N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride	BDIP-0001
placebo	Placebo	Vehicle
comparator	Chlorhexidine gluconate	Chlorhexidine gluconate

Primary Outcome Measures

Name	Time	Method
Percentage of Abdominal Site Responder Rates at 10 Minutes	10 min	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."
Percentage of Abdominal Site Responder Rates at 6 Hours	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.
Percentage of Groin Sites Responder Rates at 10 Minutes	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."
Percentage of Groin Site Responder Rate at 6 Hours	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.