Trial Outcomes & Findings for Efficacy of Silver Nanoparticle Gel Versus a Common Antibacterial Hand Gel (NCT NCT00659204)
NCT ID: NCT00659204
Last Updated: 2026-01-23
Results Overview
Subjects' hands are contaminated with 1.5 milliliters (mL) aliquot of S. marcescens which is then distributed evenly over both hands. A 30 second massage with bacteria followed by one minute of timed air drying takes place prior to the modified glove juice sampling procedure. Subject's dominant hand is placed into a sterile 1 liter polyethylene bag with 75 mL of sampling solution. Hand is removed after 60 seconds of massage and 5 mL of juice is retrieved, diluted 1:10 within 5 minutes, and plated in duplicate on trypticase soy agar. Samples are transported in bio-transport container to the lab where they are incubated aerobically at 36 degrees Centigrade for 36 hours.
TERMINATED
PHASE3
22 participants
Baseline
2026-01-23
Participant Flow
We assessed 24 subjects for eligibility. 2 did not meet inclusion criteria which left us with 22 subjects who were randomized into two groups; 11 in each group.
Participant milestones
| Measure |
Nano-silver Gel
Silver Nanoparticle Gel (SilvaSorb, AcryMed, Inc., Portland, OR)
|
Alcohol-based Gel
alcohol-based hand gel (Purell, GoJo Industries, Akron, OH)
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Silver Nanoparticle Gel Versus a Common Antibacterial Hand Gel
Baseline characteristics by cohort
| Measure |
Nano-silver Gel
n=11 Participants
Silver Nanoparticle Gel (SilvaSorb, AcryMed, Inc., Portland, OR)
|
Alcohol-based Gel
n=11 Participants
alcohol-based hand gel (Purell, GoJo Industries, Akron, OH)
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
22 Participants
n=22 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
|
Sex/Gender, Customized
Female
|
0 particpants
n=11 Participants
|
0 particpants
n=11 Participants
|
0 particpants
n=22 Participants
|
|
Sex/Gender, Customized
Male
|
11 particpants
n=11 Participants
|
11 particpants
n=11 Participants
|
22 particpants
n=22 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=11 Participants
|
11 participants
n=11 Participants
|
22 participants
n=22 Participants
|
PRIMARY outcome
Timeframe: BaselineSubjects' hands are contaminated with 1.5 milliliters (mL) aliquot of S. marcescens which is then distributed evenly over both hands. A 30 second massage with bacteria followed by one minute of timed air drying takes place prior to the modified glove juice sampling procedure. Subject's dominant hand is placed into a sterile 1 liter polyethylene bag with 75 mL of sampling solution. Hand is removed after 60 seconds of massage and 5 mL of juice is retrieved, diluted 1:10 within 5 minutes, and plated in duplicate on trypticase soy agar. Samples are transported in bio-transport container to the lab where they are incubated aerobically at 36 degrees Centigrade for 36 hours.
Outcome measures
| Measure |
Nano-silver Gel
n=11 Participants
Silver Nanoparticle Gel (SilvaSorb, AcryMed, Inc., Portland, OR)
|
Alcohol-based Gel
n=11 Participants
alcohol-based hand gel (Purell, GoJo Industries, Akron, OH)
|
|---|---|---|
|
Microbial Count at Baseline
|
105 CFU/mL
Standard Deviation 7.1
|
107 CFU/mL
Standard Deviation 8.1
|
PRIMARY outcome
Timeframe: 10 minutesPopulation: Everyone was included, there were no drop outs.
Microbial count of hands seeded with S. marcescens after ten minutes of exposure and treatment with an antimicrobial gel. Same modified glove juice sampling technique was used and 1.5 milliliters of juice was removed, diluted, and plated for incubation.
Outcome measures
| Measure |
Nano-silver Gel
n=11 Participants
Silver Nanoparticle Gel (SilvaSorb, AcryMed, Inc., Portland, OR)
|
Alcohol-based Gel
n=11 Participants
alcohol-based hand gel (Purell, GoJo Industries, Akron, OH)
|
|---|---|---|
|
Microbial Count - Persistent Effect
|
65 CFU/mL
Standard Deviation 9.4
|
103 CFU/mL
Standard Deviation 8.7
|
PRIMARY outcome
Timeframe: 1 minutePopulation: All subjects included, there were no drop outs.
Subjects underwent the modified glove juice technique after seeding of hands with S. marcescens bacteria for 1 minute followed by application of one of the two antimicrobial gels; a 1.5 milliliter sample of the juice was collected after 1 minute. The procedure was repeated for each of the two gels, random order assigned.
Outcome measures
| Measure |
Nano-silver Gel
n=11 Participants
Silver Nanoparticle Gel (SilvaSorb, AcryMed, Inc., Portland, OR)
|
Alcohol-based Gel
n=11 Participants
alcohol-based hand gel (Purell, GoJo Industries, Akron, OH)
|
|---|---|---|
|
Microbial Count - Immediate Effect
|
101 CFU/mL
Standard Deviation 6.6
|
49 CFU/mL
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Data from all participants could be used, there were no dropouts.
User Acceptability Questionnaire - Self-assessment. Investigator-developed instrument that included 4 questions regarding the specific hand gel product applied to the participant's hands: 1) I would rate my acceptance of this product as?; 2) I would consider using this product again?; 3) I would rate my confidence in this product as?; and 4) I would recommend using this product to my co-workers?. Scale had anchors of 1 (least acceptable) to 10 (most acceptable). Total score was the sum of scores for each of the 4 questions; range was 4 to 40. there were no subscales. A score of 4 demonstrated least acceptance and score of 40 demonstrated highest acceptance.
Outcome measures
| Measure |
Nano-silver Gel
n=11 Participants
Silver Nanoparticle Gel (SilvaSorb, AcryMed, Inc., Portland, OR)
|
Alcohol-based Gel
n=11 Participants
alcohol-based hand gel (Purell, GoJo Industries, Akron, OH)
|
|---|---|---|
|
User Acceptability
|
27 score on a scale
Standard Deviation 5.7
|
33 score on a scale
Standard Deviation 5.6
|
Adverse Events
Nano-silver Gel
Alcohol-based Gel
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place