Removal of Bacterial Spores in Adults on Skin

NCT ID: NCT03372122

Last Updated: 2018-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-13
• Study Completion Date: 2018-03-07

Brief Summary

The aim of this study is to compare the effectiveness of removal of spores and dirt from the skin using a single cloth bath against a cloth bath with extra rinse step, to establish whether the extra rinse stage will lead to the removal of a higher level of spores and dirt.

Detailed Description

The purpose of this study is to evaluate and compare the ability of two test materials to remove Clostridium difficile (ATCC #700057) spores with a tripartite soil load from subjects' forearms. For this study, removal of Clostridium difficile and the associated organic soil load will be used as an indicator of potential removal efficacy for difficult-to-remove microorganisms and associated organic matter from human skin.

All test materials are currently marketed products

Conditions

General Skin Cleansing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

SAGE Chlorhexidine Gluconate Cloth

Ready to use disinfectant cloth

Group Type: ACTIVE_COMPARATOR

Chlorhexidine Gluconate

Intervention Type: DRUG

A cloth to cleanse and disinfect the skin

HUBS with Hibiclens

Dry cloths to be used with water and disinfectant

Group Type: ACTIVE_COMPARATOR

HUBS with Hibiclens

Intervention Type: COMBINATION_PRODUCT

A dry cloth to be used in combination with water and antimicrobial soap to cleanse and disinfect the skin

Interventions

Chlorhexidine Gluconate

A cloth to cleanse and disinfect the skin

Intervention Type: DRUG

HUBS with Hibiclens

A dry cloth to be used in combination with water and antimicrobial soap to cleanse and disinfect the skin

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Subjects can be of either sex, 18 to 65 years of age, and of any race.
• Subjects must be able to read and understand English.
• Subjects must possess both forearms.
• Subjects must have healthy and short (< 1 mm in length) fingernails and cuticles with no defects. Subjects must also have no nail extensions, artificial nails, or nail polish and must not be wearing any jewelry that cannot be removed from the hands/forearms prior to testing.
• Subjects must have no tattoos, active skin rashes, dermatoses, or breaks in the skin of the hands or forearms. Subjects must also have no inflammatory skin conditions, such as atopic dermatitis / eczema or psoriasis, anywhere on the body.
• 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, a heart murmur, mitral valve prolapse with heart murmur, fibromyalgia, ulcerative colitis, Crohn's disease, moderate/severe asthma requiring daily use of medication, an immunocompromised condition such as AIDS (or HIV positive), lupus, or medicated multiple sclerosis.
• Subjects must read and sign the Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and List of Restricted Products prior to participating in the study.

Exclusion Criteria

• Participation in a clinical study within 7 days of signing the informed consent for this study or current participation in another clinical study.
• Known allergies or sensitivities to latex (natural rubber), alcohols, sunscreens, deodorants, laundry detergents, inks, metals, topically-applied fragrances, cleansers, soaps, lotions, or to common antibacterial agents particularly chlorhexidine gluconate.
• Have experienced hives (raised welts) as a reaction to anything that contacted the skin.
• Use of systemic or topical antibiotic medications during either the 7-day pre-test period or on the test day.
• Use of systemic or topical steroids, other than for contraception, hormone therapy, or post-menopausal indications, during the 7-day pre-test period or on the test day. This includes steroid medications used to treat asthma.
• Have an Implanon/Nexplanon or any other dermal-implanted birth control device.
• Any prosthetic device or joint (e.g., pins, screws, plates, rods, or dental implants) anywhere in the body.
• Any type of indwelling port (or portacath) or Peripherally Inserted Central Catheter (PICC).
• Subject is pregnant, plans to become pregnant or impregnate a sexual partner within the pre-test and test periods of the study, or is nursing a child.
• Subject must not be responsible for diapering, care of wounds, intravenous management, or other bed-ridden-related care roles: have any responsibility for care of children under age 3: or be living with an immunocompromised individual.
• Any medical condition or use of any medications that, in the opinion of the Principal Investigator or consulting physician, should preclude participation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Caroline Scott

INDUSTRY

Sponsor Role: lead

Responsible Party

Caroline Scott

Product Claims Manager - Antiseptics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Russell Griggs, M.S, CCRC

Role: PRINCIPAL_INVESTIGATOR

BSLI

Locations

Bioscience Laboratories, Inc

Bozeman, Montana, United States

Countries

United States

Other Identifiers

#170104-150

Identifier Type: -

Identifier Source: org_study_id