Pilot Evaluation of Two Test Materials With a Positive Co... | NCT03861780

NCT03861780

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
Project X 26ml	Experimental	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use.	Drug: Project X 26ml
Project X 5.1ml	Experimental	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 5.1ml volume. Single use.	Drug: Project X 5.1ml
Prevantics Maxi Swabstick	Active Comparator	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. Single use.	Drug: Prevantics Maxi Swabstick

Name	Type	Description	Arm Group Labels	Other Names
Project X 26ml	Drug	Application of antiseptic drug to the inguinal and abdomen areas of the subjects	Project X 26ml

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Bacterial Microflora on the Inguinal Area	Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention	30 seconds
Change in Bacterial Microflora on the Inguinal Area	Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention	10 minutes
Change in Bacterial Microflora on the Inguinal Area	Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention	6 hours
Change in Bacterial Microflora on the Abdomen Area	Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention	30 seconds
Change in Bacterial Microflora on the Abdomen Area	Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention	10 minutes
Change in Bacterial Microflora on the Abdomen Area	Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention	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 able to read and understand English.
Subjects must have read and signed an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and List of Restricted Products prior to participating in the study, all located in the separate Informed Consent documents.
Subjects must be in good general health and have no medical diagnosis of a physical condition, such as a current or recent severe illness, medicated or uncontrolled diabetes, hepatitis B, hepatitis C, an organ transplant, mitral valve prolapse with heart murmur, fibromyalgia, ulcerative colitis, Crohn's disease, an immunocompromised condition such as AIDS (or HIV positive), lupus, or medicated multiple sclerosis.
Subjects will have test sites on the skin of the abdomen and/or inguinal free of injury and in good condition (no active skin rashes, excessive freckling, moles, scratches, breaks in the skin, etc.) and have no currently active skin diseases or skin conditions (for example, contact dermatitis, psoriasis or eczema) that may compromise subject safety or study integrity.
Subjects must have skin within 6 inches of the test sites that is free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders. Subjects with tattoos, scars, active skin rashes, or breaks in the skin of test sites, skin blemishes, such as dry scabs or warts, may be admitted at the discretion of the Principal Investigator, Subinvestigators, or Consulting Physicians.

Exclusion Criteria:

Known allergies to vinyl, latex (rubber), alcohols, metals, tapes or adhesives, inks, sunscreens, deodorants, laundry detergents, topically applied fragrances, cleansers, or to common antibacterial agents found in soaps or lotions, particularly chlorhexidine gluconate or ethanol.
Have experienced hives (raised welts) as a reaction to anything that contacted the skin.
Use of systemic or topical antibiotic medications during the 14-day pre-test period through completion of testing on the single test day.
Use of systemic or topical steroids, other than for contraception, hormone therapy, post-menopausal indications, during the 14-day pre-test period through completion of testing on the single test day. This includes steroid medications used to treat asthma. Note: topically applied hormonal steroids used for post-menopausal reasons must not get on the test sites.
Any type of port (or portacath) or Peripherally Inserted Central Catheter (PICC).
Pregnancy, plans to become pregnant or impregnate a sexual partner within the pre-test and test period of the study, or nursing a child. Female subjects must have a negative urine pregnancy test documented before treatment with test materials.
Current participation or participation in a clinical study in the past 14 days.
Any medical condition or use of any medications that, in the opinion of the Principal Investigator or consulting physicians, would preclude participation.

Contacts/Locations Module

Name	Affiliation	Role
Collette Duley	BioScience Laboratories, Inc.	Principal Investigator

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

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Project X 26ml	3.15% w/v CHG / 70% v/v IPA contained within a saturated at use applicator. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
FG001	Project X 5.1ml

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 5, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Project X 26ml	3.15% w/v CHG / 70% v/v IPA contained within a saturated at use applicator. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
BG001	Project X 5.1ml	3.15% w/v CHG / 70% v/v IPA contained within a saturated at use applicator. 5.1ml volume. Single use. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
BG002	Prevantics Maxi Swabstick	3.15% w/v CHG / 70% v/v IPA. Swabstick. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00051 BG00150 BG00251 BG003152

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00042.1(18 to 87) BG00143.4(18 to 87) BG00244.7(18 to 87) BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00022 BG00128 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00038 BG00140 BG002

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

Change in Bacterial Microflora on the Inguinal Area

Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention

The overall number of participants analyzed represents the modified intent to treat (mITT) data set. The Participant Flow was is based on the intent to treat (ITT) dataset. Additionally, each subject is able to receive 2 test products (1 on each side of their body).

Posted

Mean

Standard Deviation

log10 CFU

30 seconds

evaluable sites

ID	Title	Description
OG000	Project X 26ml	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
OG001	Project X 5.1ml	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 5.1ml volume. Single use. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
OG002	Prevantics Maxi Swabstick	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects

Units	Counts
Participants	OG00030 OG00129 OG00227
evaluable sites	OG000

Title

Denominators

Categories

Title	Measurements
	OG000-3.7± 1.4 OG001-3.1± 1.3 OG002-3.5± 1.4

Primary

Change in Bacterial Microflora on the Inguinal Area

Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention

Posted

Mean

Standard Deviation

log10 CFU

10 minutes

evaluable sites

ID	Title	Description
OG000	Project X 26ml	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
OG001	Project X 5.1ml	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 5.1ml volume. Single use. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
OG002	Prevantics Maxi Swabstick	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects

Primary

Change in Bacterial Microflora on the Inguinal Area

Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention

Posted

Mean

Standard Deviation

log10 CFU

6 hours

evaluable sites

ID	Title	Description
OG000	Project X 26ml	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
OG001	Project X 5.1ml	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 5.1ml volume. Single use. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
OG002	Prevantics Maxi Swabstick	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects

Primary

Change in Bacterial Microflora on the Abdomen Area

Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention

Posted

Mean

Standard Deviation

log10 CFU

30 seconds

evaluable sites

ID	Title	Description
OG000	Project X 26ml	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
OG001	Project X 5.1ml	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 5.1ml volume. Single use. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
OG002	Prevantics Maxi Swabstick	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects

Primary

Change in Bacterial Microflora on the Abdomen Area

Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention

Posted

Mean

Standard Deviation

log10 CFU

10 minutes

evaluable sites

ID	Title	Description
OG000	Project X 26ml	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
OG001	Project X 5.1ml	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 5.1ml volume. Single use. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
OG002	Prevantics Maxi Swabstick	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects

Primary

Change in Bacterial Microflora on the Abdomen Area

Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention

Posted

Mean

Standard Deviation

log10 CFU

6 hours

evaluable sites

ID	Title	Description
OG000	Project X 26ml	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
OG001	Project X 5.1ml	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 5.1ml volume. Single use. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
OG002	Prevantics Maxi Swabstick	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Project X 26 mL	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	51	51	1	51
EG001	Project X 5.1 mL	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 5.1 ml volume. Single use. Project X 5.1 ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	50	50	0	50
EG002	Prevantics Maxi Swabstick	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) Swabstick. Single use. Application of antiseptic drug to inguinal and abdomen areas of the subjects	51	51	0	51

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Treatment Related AE	Skin and subcutaneous tissue disorders		Non-systematic Assessment	Study-related non-serious, Treatment Emergent AE	EG0001 affected51 at risk EG0010 affected50 at risk EG0020 affected51 at risk

Title	Organization	Phone	Extension	Email
Principal Investigator II/Training Coordinator	Bioscience Laboratories	(406) 587-5735	110	cduley@biosciencelabs.com

First MCP Posted Date