- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00659204
Efficacy of Silver Nanoparticle Gel Versus a Common Antibacterial Hand Gel
A Randomized Controlled Trial of the Efficacy of a Novel Silver Nanoparticle Gel Versus a Common Antibacterial Hand Gel Against Bacterial Hand Flora
The purpose of this pilot study is to compare the antimicrobial efficacy of silver nanoparticle gel to a commercialized alcohol-based hand gel on bacterial counts isolated from the hands of 40 volunteers seeded with Serratia marcescens, a surrogate microbial marker. Specific aims of this study are: Aim #1: Compare the immediate antimicrobial efficacy of a one-time application of silver nanoparticle gel (SilvaSorb , AcryMed, Inc., Portland, OR) versus an alcohol-based hand gel (Purell, GoJo Industries, Akron, OH) in reducing transient bacterial counts isolated from hands seeded with S. marcescens.
Aim # 2: Compare the persistent antimicrobial efficacy of a one-time application of silver nanoparticle gel (SilvaSorb) versus an alcohol-based hand gel (Purell) over a 10 minute time frame in producing a persistent reduction on transient bacterial counts isolated from hands seeded with S. marcescens.
Aim # 3: Compare user acceptability of silver nanoparticle gel (SilvaSorb) versus an alcohol-based hand gel (Purell) using a self-assessment questionnaire.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Washington
-
Tacoma, Washington, United States, 98431
- Recruiting
- Madigan Army Medical Center
-
Contact:
- Mary S. McCarthy, RN, PhD, CNSN
- Email: Mary.S.McCarthy1@us.army.mil
-
Principal Investigator:
- Mary S. McCarthy, RN, PhD, CNSN
-
Sub-Investigator:
- Michael L Schlicher, RN, PhDc
-
Sub-Investigator:
- Elizabeth J. Bridges, RN, PhD, C
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age > 18 years old
- Ability to read and understand English (for consent purposes)
- Free of clinically evident dermatitis, open wounds, sores, or breaks in hand skin determined by a Visual Skin Scale (VSS).
- Free of hand jewelry or artificial nail enhancements
- Have fingernails that are clean and extend no longer than approximately one (1) mm past the nail bed
Exclusion Criteria:
- Anyone directly working in a healthcare, public health, or long term residence setting.
- Currently receiving any antibiotics, or on any other in as investigational drug, steroids or immunosuppressive therapy.
- Reports cuts, scratches, or skin disorders, or Dermatitis visualized by the PI/AI using the Visual Skin Scale (VSS).
- Reports any form of current immune disorders such as AIDS, lupus, any cancers (solid or hematopoietic), or other medical conditions such as diabetes, hepatitis, rheumatoid arthritis, or an organ transplant recipient.
- Known sensitivities or allergies to silver, alcohol, latex, soap, detergent, antibiotics.
- Any use of artificial nail enhancements or any non-removable rings
- Primary care provider or resident in a setting where someone has known impaired immunocompetence (currently receiving chemotherapy, HIV positive), requires wound care or intravenous management.
- Currently pregnant/lactating or taking care of children under the age of 3 or anyone that requires diaper changing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: nano-silver gel
|
SilvaSorb® gel applied topically to the hands with a limited exposure time of 10 minutes
Other Names:
|
Active Comparator: alcohol-based gel
|
Purell gel applied topically to the hands with a limited exposure time of 10 minutes
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Antimicrobial efficacy (as measured by the percent change in microbial counts from baseline of subjects)
Time Frame: 10 minutes
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
User acceptability (as measured by the total of points received per product from a questionnaire)
Time Frame: 10 minutes
|
10 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mary S McCarthy, RN, PhD, CNSN, Nurse Researcher, Madigan Army Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 208035
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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