Hand HygienePhase 4NCT04654182
Evaluation of the Residual Antimicrobial Efficacy of One Test Material Based on a Modification of ASTM E1115-11 Test Method
A Phase 4 study testing Chlorhexidine Gluconate in people with Hand Hygiene, run by Molnlycke Health Care AB at 1 site in United States.
Trial summary
To evaluate the residual antimicrobial effectiveness of one test product when tested using a modification of the methodology of the standardized ASTM E115-11 (2017) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Hygiene
- What is being tested?
- Chlorhexidine Gluconate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2020to 24 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects may be of either sex, between the ages of 18 and 65 years, and of any race.
- Subjects must be able to read and understand English.
- Subjects must possess both hands and all ten digits.
- Subjects must have an average baseline population of at least 1.0 x 105 colony forming units (CFU) per hand.
- Subjects must have no active skin rashes, dermatoses, hangnails, or breaks in the skin of the hands or forearms. Subjects must also have no inflammatory skin conditions, such as dermatitis, eczema, or psoriasis, anywhere on the body.
- Subjects must be in good general health and have no medical diagnosis of a physical condition, such as a current or recent severe illness, a heart murmur, mitral valve prolapse with heart murmur, congenital heart disease, an organ transplant, medicated or uncontrolled diabetes, hepatitis B, hepatitis C, an immunocompromised condition such as AIDS (or HIV positive), lupus, fibromyalgia, ulcerative colitis, Crohn's disease, asthma, heart disease, hypertension, or medicated multiple sclerosis.
- Subjects must have read and signed the Informed Consent Form, List of Restricted Products, and Allowed and Restricted Products For Hand Cleaning During Coronavirus Disease 2019 (COVID-19) Pandemic prior to participating in the study, all located in the separate Informed Consent documents. Subjects must also have a current Authorization to Use and Disclose Protected Health Information Form on file at the testing facility.
Who cannot join
- Have participated in a clinical study in the past 7 days or be currently participating in another clinical study.
- Wash the hands or applying lotion within the 2-hour period prior to baseline sampling or testing.
- Be experiencing any signs/symptoms of respiratory illness, including cough, fever (body temperature of ≥ 100.0 °F) or chills, shortness of breath or difficulty breathing, persistent pain or pressure in the chest, confusion or inability to respond to external stimuli, bluish lips/face, loss of taste/smell, sore throat, headache, nasal discharge ("runny nose"), frequent sneezing, or general fatigue / body aches.
- Have a current diagnosis of active Coronavirus Disease 2019 (COVID-19) or have been in close contact within the last 2 weeks of anyone who has been diagnosed as having contracted COVID-19.
- Have been regularly smoking or vaping over the past 2 years.
- Have limited mobility or dexterity that would hamper their ability to perform the study as directed.
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- Have known allergies or sensitivities to latex (rubber), alcohols, sunscreens, deodorants, laundry detergents, topically applied fragrances, cleansers, soaps, lotions, or to common antibacterial agents, particularly chlorohexidine gluconate.
- Have experienced hives (raised welts) as a reaction to anything that contacted the skin with the exception of plants known to cause reactions for most humans (e.g., poison oak or poison ivy).
- Have a history of anaphylactic shock, anaphylactoid reaction, or anaphylactoid shock.
- Have a known hypersensitivity to the test product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions.
- Contact the brain, cerebral membrane, middle ear and eyes with the test product and such contact must be avoided.
- Be receiving any antibiotic medications during the 7-day pre-test period through completion of the study.
- Be receiving any steroids (including steroid medications used to treat asthma) other than for contraception, hormone therapy, or menopausal purposes during the 7-day pre-test period through completion of the study.
- Have any type of port (or portacath) or Peripherally Inserted Central Catheter (PICC).
- Be nursing a child.
- Be pregnant, plan to become pregnant or impregnate a sexual partner within the pre-test and test periods of the study.
- Have any medical condition or use any medications that, in the opinion of the Principal Investigator, or Consulting Physician(s) should preclude participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bioscience Laboratories, Inc
Bozeman, Montana, 59718
About this study
To evaluate the residual antimicrobial effectiveness of one test product when tested using a modification of the methodology of the standardized ASTM E115-11 (2017)
- Conditions
- Hand Hygiene
- Being tested
- Chlorhexidine Gluconate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine GluconateDrug
Product used in accordance with manufacturers Hand Hygiene instructions
| Study group | Role | What they receive |
|---|---|---|
| Log reduction in bacterial count | Experimental | Following pre-test period qualifying participants will wash their hands with 4% CHG product 3 times a day over the 5 day study period. Bacterial counts will be taken at 6 and 12 hours after the final wash on day 5 and reductions calculated from the starting count to final count. Receives: Drug: Chlorhexidine Gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial counts
Average Log reduction in counts
Measured: at 6 hours
Bacterial Counts
Average Log reduction in counts
Measured: at 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start30 Nov 2020
- Primary completion24 Dec 2020
- Study completion24 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand HygieneStudies 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioScience Laboratories, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654182
- Sponsor's protocol ID
- #2007591-102
- Status last verified
- Feb 2021
- First submitted
- 27 Nov 2020
- Last updated
- 25 Feb 2021
- Results posted
- 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 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Residual Antimicrobial Efficacy of One Test Material Based on a Modification of ASTM E1115-11 Test Method
- ClinicalTrials.gov ID
- NCT04654182
- Acronym / sponsor ID
- #2007591-102
- Conditions
- Hand Hygiene
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Collaborators
- BioScience Laboratories, Inc.
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 24 Dec 2020 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the residual antimicrobial effectiveness of one test product when tested using a modification of the methodology of the standardized ASTM E115-11 (2017)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Log reduction in bacterial count | Experimental | Drug: Chlorhexidine GluconateFollowing pre-test period qualifying participants will wash their hands with 4% CHG product 3 times a day over the 5 day study period. Bacterial counts will be taken at 6 and 12 hours after the final wash on day 5 and reductions calculated from the starting count to final count. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects may be of either sex, between the ages of 18 and 65 years, and of any race.
- Subjects must be able to read and understand English.
- Subjects must possess both hands and all ten digits.
- Subjects must have an average baseline population of at least 1.0 x 105 colony forming units (CFU) per hand.
- Subjects must have no active skin rashes, dermatoses, hangnails, or breaks in the skin of the hands or forearms. Subjects must also have no inflammatory skin conditions, such as dermatitis, eczema, or psoriasis, anywhere on the body.
Key exclusion criteria (17 listed)
- Have participated in a clinical study in the past 7 days or be currently participating in another clinical study.
- Wash the hands or applying lotion within the 2-hour period prior to baseline sampling or testing.
- Be experiencing any signs/symptoms of respiratory illness, including cough, fever (body temperature of ≥ 100.0 °F) or chills, shortness of breath or difficulty breathing, persistent pain or pressure in the chest, confusion or inability to respond to external stimuli, bluish lips/face, loss of taste/smell, sore throat, headache, nasal discharge ("runny nose"), frequent sneezing, or general fatigue / body aches.
- Have a current diagnosis of active Coronavirus Disease 2019 (COVID-19) or have been in close contact within the last 2 weeks of anyone who has been diagnosed as having contracted COVID-19.
- Have been regularly smoking or vaping over the past 2 years.
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 |
|---|---|---|
| Chlorhexidine GluconateProduct used in accordance with manufacturers Hand Hygiene instructions | Drug | Log reduction in bacterial count |
Primary outcome
Bacterial counts
Time frame: at 6 hours
Average Log reduction in counts
Bacterial Counts
Time frame: at 12 hours
Average Log reduction in counts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorhexidine Gluconate in people with Hand Hygiene, run by Molnlycke Health Care AB 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 7 inclusion and 17 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: finished, as of the sponsor's last update on 25 Feb 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bacterial counts (time frame: at 6 hours). The study lists 2 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 25 Feb 2021.