Removal of Bacterial Spores in Adults on Skin

NCT03372122 | Completed Phase 4 FDA Drug FDA Device

• 1 other identifier: #170104-150
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

General Skin Cleansing

Outcome Measures

Primary Outcomes (1)

• 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

  As a measure of the ability of the test materials to remove spores from the skin, reductions will be calculated by subtracting the population of spores recovered from a treated sites from the population recovered from the baseline sites.

  2 hours

Study Arms (2)

SAGE Chlorhexidine Gluconate Cloth

ACTIVE COMPARATOR

Ready to use disinfectant cloth

Drug: Chlorhexidine Gluconate

HUBS with Hibiclens

ACTIVE COMPARATOR

Dry cloths to be used with water and disinfectant

Combination Product: HUBS with Hibiclens

Interventions

Chlorhexidine Gluconate DRUG

A cloth to cleanse and disinfect the skin

SAGE Chlorhexidine Gluconate Cloth

HUBS with Hibiclens COMBINATION_PRODUCT

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

HUBS with Hibiclens

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Caroline Scott: lead

Study Sites (1)

Bioscience Laboratories, Inc

Bozeman, Montana, 59718, United States

Location

MeSH Terms

Interventions

chlorhexidine gluconate

Study Officials

• Russell Griggs, M.S, CCRC

  BSLI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Product Claims Manager - Antiseptics

Model Details: The two study products will be assigned to opposite forearms per a computer-generated randomization schedule. Additionally, the location for baseline and post-product samples will be randomly assigned to the two longitudinally-arranged sites per forearm.

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 13, 2017
• Study Start: December 13, 2017
• Primary Completion: January 8, 2018
• Study Completion: March 7, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-03

Locations

US (1)