Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation

NCT03224299 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MPS-16IPVFT05
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Preoperative Skin Preparation

Outcome Measures

Primary Outcomes (1)

• Antimicrobial Activity of the Investigational Products Compared to Control.

  10 minutes

Secondary Outcomes (1)

• Responder Rate at 6 Hours Post-application

  6 hours

Study Arms (4)

Investigational Product #1 (IP1)

EXPERIMENTAL

octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear

Drug: OCT - clear

Investigational Product #2 (IP2)

EXPERIMENTAL

octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted

Drug: OCT- tinted

Active Control

ACTIVE COMPARATOR

ChloraPrep® - Hi-Lite Orange® applicator

Other: ChloraPrep

Negative Control

PLACEBO COMPARATOR

sterile 0.9% saline applied with single use applicator

Other: Saline

Interventions

OCT - clear DRUG

Investigational Product #1: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear

Investigational Product #1 (IP1)

OCT- tinted DRUG

Investigational product #2: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted

Investigational Product #2 (IP2)

ChloraPrep OTHER

Active Control: ChloraPrep® - Hi-Lite Orange® applicator

Active Control

Saline OTHER

Negative Control: sterile 0.9% saline applied with single use applicator

Negative Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (2)

BioScience Laboratories

Bozeman, Montana, 59718, United States

Location

BioScience Laboratories

Butte, Montana, 59701, United States

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Erin Zook
• Organization: Becton Dickinson

erin.zook@bd.com

224-358-5019

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 21, 2017
• Study Start: June 21, 2017
• Primary Completion: August 24, 2017
• Study Completion: October 3, 2017
• Last Updated: April 23, 2021
• Results First Posted: April 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)