Evaluation of the Antimicrobial Effectiveness of an Antimicrobial Cloth

A Randomized Single Center Blinded Clinical Evaluation of the Antimicrobial Effectiveness of an Antimicrobial Cloth Compared to Vehicle and 0.9% Saline

Healthy volunteers will receive treatment to two body locations with the investigational product and placebo and the antimicrobial effectiveness of each treatment will be measured.

Study Overview

• Status: Completed
• Conditions: Preoperative Skin Preparation
• Intervention / Treatment: Drug: Octenidine Dihydrocloride in aqueous solution; Other: Vehicle Control; Other: Saline Control

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Montana
    • Bozeman, Montana, United States, 59718
      • BioScience Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and/or females, at least 18 years or older and of any race.
• Are in good general health.
• Unable to become pregnant, or willing to use an acceptable method of contraception (i.e. oral contraception, intra-uterine device [IUD], diaphragm, condom, abstinence, bilateral Tubal ligation, or are in a monogamous relationship with a partner who has had a Vasectomy) to prevent pregnancy for at least 14 days immediately preceding Treatment Day and throughout the duration of the study, if female of child-bearing potential.
• All female subjects must have a negative urine pregnancy test on Treatment Day prior to any applications of the study products.
• Have skin within 6 inches of the test sites that is free of dermatoses, abrasions, cuts, lesions or other skin disorders.
• Cooperative and willing to follow Subject Instructions
• Cooperative and willing to sign Consent Form and HIPAA Authorization Form.
• Able to read, write and follow instructions in English.

Exclusion Criteria:

• Exposure to topical or systemic antimicrobials or any other product known to affect the normal microbial flora of the skin, antibiotics or steroids (other than hormones for contraception or post-menopausal reasons) exposure within 14 days prior to Treatment Day and for the remainder of the study. Restrictions include, but are not limited to antimicrobial-containing soaps, antiperspirants/deodorants, shampoos, lotions, perfumes, after shaves, and colognes.
• Swimming in chemically treated pools or bathing in hot tubs, spas and whirlpools within 14 days prior to Treatment Day and for the remainder of the study.
• Use of tanning beds, hot waxes, or depilatories, including shaving (in the applicable test areas) within 14 days prior to Treatment Day and for the remainder of the study.
• Contact with strong detergents, solvents, acids, bases, bug repellant, fabric softener-treated clothing, UV treated clothing or other household chemicals in the applicable test areas within 14 days of the Treatment Day and for the remainder of the study.
• Subjects who have a history of sensitivity to vinyl, natural rubber latex, adhesive skin products (e.g., Band-Aids, medical tapes), polyester, metals, inks, common antibacterial agents found in common personal beauty or personal care soaps, lotions, or ointments
• Subjects who have asthma requiring medication, diabetes, hepatitis B or C, an organ transplant, mitral valve prolapse with a heart murmur, congenital heart disease, lupus, Crohn's disease, medicated multiple sclerosis, internal prosthesis or any immunocompromised conditions (such as AIDS or HIV positive).
• Subjects who have a history of skin allergies.
• Subjects who have a history of skin cancer within 6 inches of the applicable test areas or have received treatment for any type of internal cancer within the 5 years prior to enrollment.
• Any tattoos or scars on the test sites or 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, and eczema) anywhere on the body.
• Subjects who are pregnant, attempting pregnancy, or nursing.
• Subjects who have showered or bathed within at least 72 hours of the Treatment Day (sponge baths may be taken, however, the lower abdomen and upper thigh region must be avoided).
• 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 Treatment Day baseline sample collection.
• Participation in another clinical trial in the 30 days prior to signing the informed consent for this study, current enrollment in another clinical trial, or have already participated in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Investigational Product; Polyester cloth impregnated with investigational product	Drug: Octenidine Dihydrocloride in aqueous solution; application of investigational product
PLACEBO_COMPARATOR: Vehicle Control (VC); Polyester cloth impregnated with the vehicle control	Other: Vehicle Control; application of vehicle control
PLACEBO_COMPARATOR: Saline Control (SC); Saline applied wtih polyester cloth	Other: Saline Control; application of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bacterial Count at 10 Minutes Post Application	10 minutes after application of test product

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company
• Investigators: Principal Investigator: Christopher Beausoleil, BioScience Laboratories

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 21, 2017
• Primary Completion (ACTUAL): August 4, 2017
• Study Completion (ACTUAL): August 4, 2017

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (ACTUAL): July 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 23, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Octenidine
• Other Study ID Numbers: MPS-17IPVAW10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No