Efficacy of Silver Nanoparticle Gel Versus a Common Antibacterial Hand Gel
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|ClinicalTrials.gov Identifier: NCT00659204|
Recruitment Status : Unknown
Verified April 2008 by Madigan Army Medical Center.
Recruitment status was: Recruiting
First Posted : April 16, 2008
Last Update Posted : April 16, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Normal Subjects||Drug: nano-silver gel exposed Drug: alcohol-based hand gel||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial of the Efficacy of a Novel Silver Nanoparticle Gel Versus a Common Antibacterial Hand Gel Against Bacterial Hand Flora|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||August 2008|
|Estimated Study Completion Date :||August 2008|
|Experimental: nano-silver gel||
Drug: nano-silver gel exposed
SilvaSorb® gel applied topically to the hands with a limited exposure time of 10 minutes
Other Name: SilvaSorb® gel
|Active Comparator: alcohol-based gel||
Drug: alcohol-based hand gel
Purell gel applied topically to the hands with a limited exposure time of 10 minutes
Other Name: Purell
- Antimicrobial efficacy (as measured by the percent change in microbial counts from baseline of subjects) [ Time Frame: 10 minutes ]
- User acceptability (as measured by the total of points received per product from a questionnaire) [ Time Frame: 10 minutes ]
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): NCT00659204
|United States, Washington|
|Madigan Army Medical Center||Recruiting|
|Tacoma, Washington, United States, 98431|
|Contact: Mary S. McCarthy, RN, PhD, CNSN 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|
|Principal Investigator:||Mary S McCarthy, RN, PhD, CNSN||Nurse Researcher, Madigan Army Medical Center|