HealthyPhase 3NCT00659204
Efficacy of Silver Nanoparticle Gel Versus a Common Antibacterial Hand Gel
A Phase 3 study testing Silver Nanoparticle Gel and alcohol-based hand gel in people with Healthy, run by Madigan Army Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Silver Nanoparticle Gel and alcohol-based hand gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Aug 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
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
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.
Read the detailed description
The objective of this randomized controlled, double blinded, 2x3 experimental study is to evaluate the antimicrobial efficacy of silver nanoparticle gel compared to an alcohol-based hand gel on bacterial counts isolated from the hands of 40 healthy, adult, military student volunteers. The study will be conducted in two phases: the first phase will consist of a methods development period and the second phase will consist of the formal pilot study. For phase I, the first four participants from the sample pool will be assigned into one of two groups (nano-silver gel or alcohol-based gel) whereas in Phase II, the participants will be randomized into one of two groups. Participants in both phases will follow a 7 day washout period where subjects will refrain from using antimicrobial products for a week prior to testing. Testing of participants in both phases will start with a baseline bacterial hand count. This will be accomplished by using a surrogate biomarker (S. Marcescens). This microorganism was selected because it is considered the standard surrogate marker to be used in hand hygiene evaluations and because it produces a characteristic red colony that is easily distinguishable from normal microbial populations of the hands making colony counting more accurate. Sampling of bacterial flora will be accomplished utilizing an established "modified glove juice" technique in which the participant's dominant hand is placed into a large sterile bag containing a sampling solution, which removes the surrogate bacteria. Once baseline samples have been collected, all participants will then complete two additional random ordered timed conditions involving the surrogate biomarker and one of the two test gels. For each test condition, five mL of solution will be withdrawn from the collection bag, diluted, plated, and incubated for 36 hours. For the immediate efficacy testing, a glove juice sampling will be obtained after a 1 minute application of the gel. For the persistent efficacy testing, a glove juice sampling will be obtained after a 10 minute application of the gel. To ensure the biomarker has been removed, all subjects will wash hands with a 70% ethanol surgical handwash. The use of an UV-C light will also be implemented for 20 seconds as an additional precaution. Participants in phase I will have an additional glove juice sampling at the end of degerming to validate the protocol. All participants will end the study by completing a 4 question visual analog questionnaire to determine user acceptability of the gels. The percent difference of total bacterial counts from baseline will be used as the outcome variable. An unpaired Student's t-test (or an appropriate non-parametric test) will be used for data analysis for each of the study aims.
- Conditions
- Healthy
- Being tested
- Silver Nanoparticle Gel, alcohol-based hand gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Nanoparticle GelDrug
Also called SilvaSorb® gel
SilvaSorb® gel applied topically to the hands with a limited exposure time of 10 minutes
alcohol-based hand gelDrug
Also called Purell
Purell gel applied topically to the hands with a limited exposure time of 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Silver Nanoparticle Gel | Experimental | Silver Nanoparticle Gel (SilvaSorb, AcryMed, Inc., Portland, OR) Receives: Drug: Silver Nanoparticle Gel |
| alcohol-based gel | Active comparator | Alcohol-based hand gel (Purell, GoJo Industries, Akron, OH) Receives: Drug: alcohol-based hand gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial Count at 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.
Measured: Baseline
Microbial Count - Persistent Effect
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.
Measured: 10 minutes
Microbial Count - Immediate Effect
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.
Measured: 1 minute
Secondary outcomes (1)
User Acceptability
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: Researcher left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madigan Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mary S McCarthy, PhD, MN, Principal investigator, Nurse Scientist, Madigan Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659204
- Sponsor's protocol ID
- 208035
- Status last verified
- Sep 2025
- First submitted
- 11 Apr 2008
- Last updated
- 23 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00659204
- Acronym / sponsor ID
- 208035
- Conditions
- Healthy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Researcher left the institution
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Madigan Army Medical CenterUS federal agency
- Study start
- Jan 2008 (actual)
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 16 Apr 2008 (estimated)
- Results
- Posted 23 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this randomized controlled, double blinded, 2x3 experimental study is to evaluate the antimicrobial efficacy of silver nanoparticle gel compared to an alcohol-based hand gel on bacterial counts isolated from the hands of 40 healthy, adult, military student volunteers. The study will be conducted in two phases: the first phase will consist of a methods development period and the second phase will consist of the formal pilot study. For phase I, the first four participants from the sample pool will be assigned into one of two groups (nano-silver gel or alcohol-based gel) whereas in Phase II, the participants will be randomized into one of two groups. Participants in both phases will follow a 7 day washout period where subjects will refrain from using antimicrobial products for a week prior to testing. Testing of participants in both phases will start with a baseline bacterial hand count. This will be accomplished by using a surrogate biomarker (S. Marcescens). This microorganism was selected because it is considered the standard surrogate marker to be used in hand hygiene evaluations and because it produces a characteristic red colony that is easily distinguishable from normal microbial populations of the hands making colony counting more accurate. Sampling of bacterial flora will be accomplished utilizing an established "modified glove juice" technique in which the participant's dominant hand is placed into a large sterile bag containing a sampling solution, which removes the surrogate bacteria. Once baseline samples have been collected, all participants will then complete two additional random ordered timed conditions involving the surrogate biomarker and one of the two test gels. For each test condition, five mL of solution will be withdrawn from the collection bag, diluted, plated, and incubated for 36 hours. For the immediate efficacy testing, a glove juice sampling will be obtained after a 1 minute application of the gel. For the persistent efficacy testing, a glove juice sampling will be obtained after a 10 minute application of the gel. To ensure the biomarker has been removed, all subjects will wash hands with a 70% ethanol surgical handwash. The use of an UV-C light will also be implemented for 20 seconds as an additional precaution. Participants in phase I will have an additional glove juice sampling at the end of degerming to validate the protocol. All participants will end the study by completing a 4 question visual analog questionnaire to determine user acceptability of the gels. The percent difference of total bacterial counts from baseline will be used as the outcome variable. An unpaired Student's t-test (or an appropriate non-parametric test) will be used for data analysis for each of the study aims.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silver Nanoparticle Gel | Experimental | Drug: Silver Nanoparticle GelSilver Nanoparticle Gel (SilvaSorb, AcryMed, Inc., Portland, OR) |
| alcohol-based gel | Active comparator | Drug: alcohol-based hand gelAlcohol-based hand gel (Purell, GoJo Industries, Akron, OH) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver Nanoparticle GelAlso: SilvaSorb® gelSilvaSorb® gel applied topically to the hands with a limited exposure time of 10 minutes | Drug | Silver Nanoparticle Gel |
| alcohol-based hand gelAlso: PurellPurell gel applied topically to the hands with a limited exposure time of 10 minutes | Drug | alcohol-based gel |
Primary outcome
Microbial Count at Baseline
Time frame: 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.
Microbial Count - Persistent Effect
Time frame: 10 minutes
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.
Microbial Count - Immediate Effect
Time frame: 1 minute
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.
1 secondary outcome
User Acceptability
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary S McCarthy, PhD, MN principal investigator
Nurse Scientist, Madigan Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Silver Nanoparticle Gel and alcohol-based hand gel in people with Healthy, run by Madigan Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial Count at Baseline (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.