Efficacy of Silver Nanoparticle Gel Versus a Common Antibacterial Hand Gel

NCT00659204 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 208035
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  1 minute

Secondary Outcomes (1)

• User Acceptability

  2 hours

Study Arms (2)

Silver Nanoparticle Gel

EXPERIMENTAL

Silver Nanoparticle Gel (SilvaSorb, AcryMed, Inc., Portland, OR)

Drug: Silver Nanoparticle Gel

alcohol-based gel

ACTIVE COMPARATOR

Alcohol-based hand gel (Purell, GoJo Industries, Akron, OH)

Drug: alcohol-based hand gel

Interventions

Silver Nanoparticle Gel DRUG

SilvaSorb® gel applied topically to the hands with a limited exposure time of 10 minutes

Also known as: SilvaSorb® gel

Silver Nanoparticle Gel

alcohol-based hand gel DRUG

Purell gel applied topically to the hands with a limited exposure time of 10 minutes

Also known as: Purell

alcohol-based gel

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Madigan Army Medical Center: lead

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Limitations and Caveats

Further investigation is warranted to test silver nanoparticle gel as a persistent antibacterial therapeutic.

Results Point of Contact

• Title: Mary McCarthy, Ph.D.
• Organization: Madigan Army Medical Center

mary.s.mccarthy1.civ@health.mil

253-968-3695

Study Officials

• Mary S McCarthy, PhD, MN

  Nurse Scientist, Madigan Army Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2008
• First Posted: April 16, 2008
• Study Start: January 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: January 23, 2026
• Results First Posted: January 23, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)