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Removal of Bacterial Spores in Adults on Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03372122
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Caroline Scott, Molnlycke Health Care AB

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.

Condition or disease Intervention/treatment Phase
General Skin Cleansing Drug: Chlorhexidine Gluconate Combination Product: HUBS with Hibiclens Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Ability of Two Products to Remove Bacterial Spores From Subjects' Forearms
Actual Study Start Date : December 13, 2017
Actual Primary Completion Date : January 8, 2018
Actual Study Completion Date : March 7, 2018


Arm Intervention/treatment
Active Comparator: SAGE Chlorhexidine Gluconate Cloth
Ready to use disinfectant cloth
Drug: Chlorhexidine Gluconate
A cloth to cleanse and disinfect the skin

Active Comparator: HUBS with Hibiclens
Dry cloths to be used with water and disinfectant
Combination Product: HUBS with Hibiclens
A dry cloth to be used in combination with water and antimicrobial soap to cleanse and disinfect the skin




Primary Outcome Measures :
  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 [ Time Frame: 2 hours ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372122


Locations
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United States, Montana
Bioscience Laboratories, Inc
Bozeman, Montana, United States, 59718
Sponsors and Collaborators
Caroline Scott
Investigators
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Principal Investigator: Russell Griggs, M.S, CCRC BSLI
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Responsible Party: Caroline Scott, Product Claims Manager - Antiseptics, Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT03372122    
Other Study ID Numbers: #170104-150
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents