Effectiveness of an Antimicrobial Agent for Preoperative... | NCT03224299

NCT03224299

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
OCT - clear	Drug	Investigational Product #1: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear	Investigational Product #1 (IP1)

Outcomes Module

Measure	Description	Time Frame
Antimicrobial Activity of the Investigational Products Compared to Control.		10 minutes

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

Eligibility Module

Eligibility Criteria

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.

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
BioScience Laboratories		Bozeman	Montana	59718	United States
BioScience Laboratories

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Number of participants enrolled is 131. Each participant has up to 4 sites on their body treated with assigned products. Participants are treated bilaterally on the abdomen and/or groin based on passing screening criteria.

Arm/Group Information

ID	Title	Description
FG000	Number of Participants	Participants were treated with 2 of 4 study products (IP#1 [OCT/IPA-clear], IP#2 [OCT/IPA-tinted], AC [ChloraPrep Hi-Lite Orange], or NC [0.9% saline]), 1 on the left side of the body (abdomen and inguen received the same product) and 1 on the right (abdomen and inguen received the same product). Therefore, treatment groups are not discrete categories and cannot be described by treatment group.
FG001	Number of Sites	Test sites on body

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED	Enrolled	FG000131 subjects FG001424 subjects
Treated With IP#1		FG00065 subjects FG001101 subjects
Treated With IP#2		FG00066 subjects FG001107 subjects
Treated With AC		FG00066 subjects FG001110 subjects
Treated With NC		FG00065 subjects FG001106 subjects
COMPLETED		FG000131 subjects FG001424 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects

Baseline Characteristics Module

ID	Title	Description
BG000	Treated Subjects	All treated subjects

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Antimicrobial Activity of the Investigational Products Compared to Control.

Analysis only includes participants with required treatment day baseline bacterial counts at each anatomical site at baseline and non-missing data at 30 seconds and 10 minutes.

Posted

Mean

Standard Deviation

log10 CFU/cm^2

10 minutes

ID	Title	Description
OG000	Investigational Product #1	Octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear
OG001	Investigational Product #2	Octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted
OG002

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IP#1	Investigational Product #1 (IP1) Octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Erin Zook	Becton Dickinson	224-358-5019		erin.zook@bd.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 19, 2017	Dec 11, 2020	Prot_001.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Aug 2, 2017	Dec 11, 2020	SAP_002.pdf

Submission Tracking

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

ID	Term
D012965	Sodium Chloride

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Masking Info

Title	Measurements
	OG0000.98± 1.31 OG0011.05± 1.23 OG0021.34± 1.24 OG0033.42± 0.72

Title	Measurements
	OG0001.20± 1.30 OG0010.91± 1.15 OG0021.08± 1.10 OG0033.12± 0.87

Title	Measurements
	OG0002.91± 1.26 OG0013.03± 1.16 OG0023.05± 1.19 OG0035.11± 0.41

Title	Measurements
	OG0002.37± 1.34 OG0012.66± 1.37 OG0022.66± 1.42 OG0034.91± 0.43