Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation

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

Study Overview

• Status: Completed
• Conditions: Preoperative Skin Preparation
• Intervention / Treatment: Drug: OCT - clear; Drug: OCT- tinted; Other: ChloraPrep; Other: Saline

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Montana
    • Bozeman, Montana, United States, 59718
      • BioScience Laboratories
    • Butte, Montana, United States, 59701
      • 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:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Investigational Product #1 (IP1); octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear	Drug: OCT - clear; Investigational Product #1: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear
EXPERIMENTAL: Investigational Product #2 (IP2); octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted	Drug: OCT- tinted; Investigational product #2: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted
ACTIVE_COMPARATOR: Active Control; ChloraPrep® - Hi-Lite Orange® applicator	Other: ChloraPrep; Active Control: ChloraPrep® - Hi-Lite Orange® applicator
PLACEBO_COMPARATOR: Negative Control; sterile 0.9% saline applied with single use applicator	Other: Saline; Negative Control: sterile 0.9% saline applied with single use applicator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 21, 2017
• Primary Completion (ACTUAL): August 24, 2017
• Study Completion (ACTUAL): October 3, 2017

Study Registration Dates

• First Submitted: July 10, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (ACTUAL): July 21, 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

• Other Study ID Numbers: MPS-16IPVFT05

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