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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

22 participants

Primary outcome timeframe

Baseline

Results posted on

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

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

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: Baseline

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.

Outcome measures

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 minutes

Population: 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

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 minute

Population: 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

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 hours

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Alcohol-based Gel

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mary McCarthy, Ph.D.

Madigan Army Medical Center

Phone: 253-968-3695

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place