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CompletedNCT03372122Updated Mar 13, 2018

Removal of Bacterial Spores in Adults on Skin

A Phase 4 interventional study of Chlorhexidine Gluconate and HUBS with Hibiclens in General Skin Cleansing, sponsored by Caroline Scott. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-13.

Sponsored by Caroline Scott · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • General Skin Cleansing
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Active comparator
    SAGE Chlorhexidine Gluconate Cloth

    Ready to use disinfectant cloth

    Drug: Chlorhexidine Gluconate

  • Active comparator
    HUBS with Hibiclens

    Dry cloths to be used with water and disinfectant

    Combination Product: HUBS with Hibiclens

Interventions

  • DrugChlorhexidine Gluconate

    A cloth to cleanse and disinfect the skin

  • Combination productHUBS with Hibiclens

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

05

What researchers measure

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.

    Time frame: 2 hours

06

Study locations

1 site
  • Bioscience Laboratories, Inc
    Bozeman, Montana 59718, United States
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03372122
Lead sponsor
Caroline Scott
Responsible party
Caroline Scott (Product Claims Manager - Antiseptics, Molnlycke Health Care AB) — Sponsor-investigator
First posted
Dec 13, 2017
Start date
Dec 13, 2017
Primary completion
Jan 8, 2018
Completion
Mar 7, 2018
Last update
Mar 13, 2018

Study contacts

Russell Griggs, M.S, CCRC
principal investigator · BSLI

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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