Evaluation of the Antimicrobial Effectiveness of CHG/IPA

NCT04035161 | Completed Results

• 1 other identifier: MPS-17IPVSS02
• Study Type: interventional
• Target: 1,935
• Locations: 1 country
• Sites: 1

Brief Summary

This single site study is a randomized, controlled, partially-blinded design enrolling a minimum of 516 healthy volunteers, where each subject will receive two of the planned study products on the product application sites of the abdomen and/or groin.

Conditions

Microbial Colonization

Outcome Measures

Primary Outcomes (4)

• Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application

  Bacterial log10/cm\^2 reductions for abdominal and groin sites post-product application (30 seconds and 6 hours) using the Investigational Product or Reference Standard.

  30 seconds and 6 hours post-product application

• Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application.

  Evaluation of antimicrobial activity will be based on log10 CFU/cm2 of resident microbes on skin before and after each product application on the abdomen and groin.

  Baseline and 10 minutes post-product application

• Responder Rate at 6 Hours Post-Product Application on the Abdomen.

  Number of participants with bacterial reduction greater than or equal to baseline (0).

  6 hours post-product application

• Responder Rate at 6 Hours Post-Product Application on the Groin.

  Number of participants with bacterial reduction greater than or equal to baseline (0).

  6 hours post-product application

Secondary Outcomes (1)

• Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application.

  Baseline and 30 seconds post-product application

Study Arms (4)

Investigational Product

EXPERIMENTAL

Skin will be prepared with investigational product

Combination Product: Investigational Product

Reference Standard

OTHER

Skin will be prepared with reference standard

Other: Reference Standard

Active Control

ACTIVE COMPARATOR

Skin will be prepared with active comparator

Combination Product: Active Comparator

Negative Control

OTHER

Skin will be prepared with negative control

Other: Negative Control

Interventions

Investigational Product COMBINATION_PRODUCT

2%(w/v) Chlorhexidine in 70%(v/v) Isopropyl skin preparation

Investigational Product

Reference Standard OTHER

60% (v/v) 1-propanol skin preparation

Reference Standard

Active Comparator COMBINATION_PRODUCT

ChloraPrep® SEPP® skin preparation

Active Control

Negative Control OTHER

0.9% Normal Saline skin preparation

Negative Control

Eligibility Criteria

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

You may qualify if:

• Read, understand, and provide signed informed consent.
• Are healthy subjects in good general health
• Are 18 years of age or older
• If females of childbearing potential, are using an acceptable form of birth control for at least 28 days immediately preceding Day 1 and throughout the duration of the study. Acceptable methods are established, effective hormonal contraception (oral/implant/injectable/transdermal/intra-vaginal), intra-uterine device \[IUD\], diaphragm with spermicide, condom with spermicide, abstinence, bilateral tubal ligation, or are in a monogamous relationship with a partner who has had a vasectomy
• In the case of females of childbearing potential, have a negative urine pregnancy test (UPT) on Product Application Day prior to any applications of the study products.
• Are free of any systemic or dermatologic disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs.
• Have minimal Screening Day bacterial count.

You may not qualify if:

• Have had 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) within the product restriction period and for the remainder of the study. Restrictions include, but are not limited to antimicrobial soaps, antiperspirants/deodorants, shampoos, lotions, perfumes, after shaves, and colognes.
• Subjects who have a history of skin allergies.
• Have known allergies or sensitivity to vinyl, latex (rubber), alcohols, metals, inks, common consumer/beauty products, tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine, or any other product components.
• Swimming in chemically treated pools or bathing in hot tubs, spas and whirlpools within the product restriction period and for the remainder of the study.
• Use of tanning beds, hot waxes, or depilatories, including shaving (in the applicable product application areas) within the product restriction period and for the remainder of the study.
• Have had exposure of the product application sites to strong detergents, acids, bases, bug repellant, fabric softener-treated clothing, UV treated clothing, other household chemicals in the applicable product application areas or other irritants during the product restriction period or during the study period.
• Have a history of skin cancer within 6 inches of applicable product application areas, or are currently being treated for skin cancer or have received treatment for any type of internal cancer within the 5 years prior to enrollment.
• Subjects who have a history of asthma, 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).
• A currently active skin disease or inflammatory skin condition (for example contact dermatitis) anywhere on the body.
• Any tattoos or scars (including stretch marks) on the product application sites or within 2 inches of the product application sites; skin blemishes or warts may be permissible with the specific approval of the 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 product application sites.
• Subjects who have showered or bathed within at least 72 hours of the Product Application Day. Sponge baths may be taken, however, the lower abdomen and upper thigh region must be avoided.
• Subjects who have an irritation score of 1 or greater (any redness, swelling, rash, or dryness present at any product application area) for any individual skin condition prior to the Product Application Day baseline sample collection.
• Are females who are pregnant, plan to become pregnant during the study, or are breastfeeding a child.
• Are unable to adhere to or understand the protocol.

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (1)

Eurofins Evic Product Testing Romania S.R.L.

Bucharest, 040256, Romania

Location

MeSH Terms

Conditions

Communicable Diseases

Interventions

Reference Standards

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Weights and Measures; Investigative Techniques

Results Point of Contact

• Title: Erin Zook, PhD
• 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
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study products cannot be blinded to staff member(s) performing product applications, sample collections. Staff member(s) performing bacterial enumeration will be blinded from the identification of all study product assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Healthy adult volunteers that meet inclusion/exclusion criteria will be randomized to receive 2 of the 4 products on bilateral site on the abdomen and/or groin.

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 29, 2019
• Study Start: April 17, 2019
• Primary Completion: December 24, 2019
• Study Completion: December 24, 2019
• Last Updated: August 17, 2021
• Results First Posted: August 17, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)