Evaluation of the Antimicrobial Effectiveness of an Antimicrobial Cloth

• Sponsor: Becton, Dickinson and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03229759
• Collaborator: (none)
• Enrollment: 99
• Location: 1
• Arms: 3
• Actual Duration (Months): 1.4
• Patients Per Site Per Month: 68.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Preoperative Skin Preparation	Drug: Octenidine Dihydrocloride in aqueous solution; Other: Vehicle Control; Other: Saline Control	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Randomized Single Center Blinded Clinical Evaluation of the Antimicrobial Effectiveness of an Antimicrobial Cloth Compared to Vehicle and 0.9% Saline
• Actual Study Start Date: Jun 21, 2017
• Actual Primary Completion Date: Aug 4, 2017
• Actual Study Completion Date: Aug 4, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Bacterial Count at 10 Minutes Post Application [10 minutes after application of test product]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BioScience Laboratories	Bozeman	Montana	United States	59718

Sponsors and Collaborators

• Becton, Dickinson and Company

Investigators

• Principal Investigator: Christopher Beausoleil, BioScience Laboratories

Study Documents (Full-Text)

• Study Protocol - May 25, 2017
• Statistical Analysis Plan - Jun 23, 2017

More Information

Publications

None provided.

• Responsible Party: Becton, Dickinson and Company
• ClinicalTrials.gov Identifier: NCT03229759
• Other Study ID Numbers: MPS-17IPVAW10
• First Posted: Jul 26, 2017
• Last Update Posted: Apr 23, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Octenidine

Study Results

Participant Flow

Pre-assignment Detail	Participants were only treated if baseline bacterial counts met the inclusion criteria. Participants were treated with 2 of 3 study products (Investigational Product, saline control, vehicle control) 1 on the left side of the body (both groin and abdomen), 1 on the right side of the body (both groin and abdomen). Therefore, treatment groups are not discrete categories.

Arm/Group Title	All Participants
Arm/Group Description	All screened participants
Period Title: Overall Study
STARTED	99
Participants Treated	69
Treated With Investigational Product	45
Treated With Vehicle Control	47
Treated With Saline Control	46
COMPLETED	69
NOT COMPLETED	30

Baseline Characteristics

Arm/Group Title	Participants Treated
Arm/Group Description	Participants who received study product at at least 1 treatment site (abdomen and/or groin). Participants were treated with 2 of 3 study products, investigational product (IP), saline control (SC), and/or vehicle control (VC). Therefore, treatments arms are not discrete groups of participants. Therefore, baseline data are presented for all treated participants and not by treatment arm.
Overall Participants	69
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41 (17)
Sex: Female, Male (Count of Participants)
Female	17 24.6%
Male	52 75.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 2.9%
Not Hispanic or Latino	63 91.3%
Unknown or Not Reported	4 5.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 1.4%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	64 92.8%
More than one race	0 0%
Unknown or Not Reported	4 5.8%
Region of Enrollment (participants) [Number]
United States	69 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Investigational Product	Saline Control	Vehicle Control
Arm/Group Description	Investigational Product (IP) - Thermally treated polyester cloths impregnated with 0.4% weight by volume octenidine dihydrochloride (OCT) aqueous solution	Saline Control (SC) - 0.9% saline applied with polyester cloths	Vehicle Control (VC) Thermally treated polyester cloths impregnated with vehicle formulation.
Measure Participants	41	41	42
Abdomen- Baseline	3.55 (0.40)	3.61 (0.41)	3.66 (0.40)
Abdomen- 10 minutes	1.19 (1.28)	2.64 (0.58)	2.56 (0.97)
Groin- Baseline	5.95 (0.60)	6.07 (0.53)	5.89 (0.47)
Groin- 10 minutes	2.98 (1.14)	4.90 (0.56)	4.25 (0.68)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Investigational Product, Saline Control
	Comments	Test on abdomen Average treatment effect was calculated using a linear regression model for each body site was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.48
	Confidence Interval	(2-Sided) 95%; 0.88 to 2.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Investigational Product, Vehicle Control
	Comments	Tested on the abdomen Analysis was performed based on deferral letters from the FDA. Average treatment effect was calculated using a linear regression model for each body site was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.34
	Confidence Interval	(2-Sided) 95%; 0.72 to 1.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Investigational Product, Saline Control
	Comments	Groin
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.93
	Confidence Interval	(2-Sided) 95%; 1.38 to 2.47
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Investigational Product, Vehicle Control
	Comments	Groin
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.26
	Confidence Interval	(2-Sided) 95%; 0.73 to 1.79
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	10 minutes
Arm/Group Title	Subject Treated
Arm/Group Description	Participants who received study product at at least 1 treatment site (abdomen and/or groin). Participants were treated with 2 of 3 study products, investigational product (IP), saline control (SC), and/or vehicle control (VC). Therefore, treatments arms are not discrete groups of participants. Therefore, adverse event data are presented for all treated participants and not by treatment arm.
All Cause Mortality
	Subject Treated
	Affected / at Risk (%)	# Events
Total	0/69 (0%)
Serious Adverse Events
	Subject Treated
	Affected / at Risk (%)	# Events
Total	0/69 (0%)
Other (Not Including Serious) Adverse Events
	Subject Treated
	Affected / at Risk (%)	# Events
Total	0/69 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.