InfectionNCT02640469
Alcohol Versus Chlorhexidine With and Without Water
A study testing Chlorhexidine with water rinse, Chlorhexidine without water rinse and Chlorhexidine + sterillium hand rub in people with Infection, run by NYU Langone Health at 1 site in United States.
Trial summary
Currently at NYU institutions, providine-iodine and chlorhexidine medicated soaps are available as hand disinfection options. The purpose of this study is to determine the relative efficacy of traditional hand scrubs with chlorhexidine with or without rinsing with water after scrubbing is complete versus dry hand rubs… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection
- What is being tested?
- Chlorhexidine with water rinse, Chlorhexidine without water rinse and Chlorhexidine + sterillium hand rub
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Jan 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Orthopedic resident or surgical employee of NY U
- Over 21 years of age
- Procedural knowledge of correct aseptic scrub technique
Who cannot join
- No surgical experience
- Under 21 years of age
- Refusal to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Hospital for Joint Disease
New York, New York, 10016
About this study
Official title: Efficacy of the Use of Alcohol-bases Solutions Versus Chlorhexidine With or Without Water for Hand Sanitation Prior to Surgical Procedure
Currently at NYU institutions, providine-iodine and chlorhexidine medicated soaps are available as hand disinfection options. The purpose of this study is to determine the relative efficacy of traditional hand scrubs with chlorhexidine with or without rinsing with water after scrubbing is complete versus dry hand rubs with alcohol.
Read the detailed description
No current recommendations exist advocating the use of Providine-iodine or Chlorhexidine. Providine-iodine is safe and effective at reducing skin colonization with gram positive and negative bacteria, mycobacterium tuberculosis, fungi and viruses. Chlorhexidine similarly disrupts cellular membranes. It is bacteriocidal and bacteriostatic and has immediate and more lasting effect than iodine because it can bind to the stratum corneum of the skin and is effective against gram positive and negative organisms, lipophilic viruses and yeasts.
All subjects who are employees of the NYU Hospital for Joint Diseases and have experience with surgical hand disinfection will be asked to enroll. Subjects will be randomized into one of three study arms using an online randomizer: (1) the standard chlorhexidine with water rinse, (2) chlorhexidine without water rinse(experimental), and (3) standard chlorhexidine followed by sterillium hand rub. After hand disinfection protocol has been completed, each subject will have each hand cultured three times using a cotton swab culture stick and sent to the microbiology lab for processing
- Conditions
- Infection
- Being tested
- Chlorhexidine with water rinse, Chlorhexidine without water rinse, Chlorhexidine + sterillium hand rub
- Keywords
- chlorhexidine, sterility, sterile hands
- Medical subject headings
- Infections, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine with water rinseOther
This procedure will be followed for both the right and left hands and arms:
scrub each side of finger, in between fingers and back and front of hands for 2 minutes, followed by scrubbing of arms, keeping hands higher than arms at all times, wash each side of the arms from wrist to elbow for 1 minute
Chlorhexidine without water rinseOther
Scrub each side of finger, in between fingers and back and front of hands for 2 minutes, proceed to scrub the arms, keeping the hand higher than the arm at all times, wash each side of the arms from wrist to elbow for 1 minute, and repeat the process on the other arm.
Chlorhexidine + sterillium hand rubOther
Scrub each side of finger, in between fingers and back and front of hands for 2 minutes, Scrub each side of finger, in between fingers and back and front of hands for 2 minutes, proceed to scrub the arms, keeping the hand higher than the arm at all times, wash each side of the arms from wrist to elbow for 1 minute, and repeat the process on the other arm. Rinse hands and arms by passing through water in one direction, dry hands, and rub 5 mL of alcohol into the palm of the hands, forearms and elbows. Ensure that the whole skin area on both arms is covered.
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine with water rinse | Active comparator | This is a traditional method of disinfection used at NYU Hospital for Joint Disease. Following disinfection protocol, each subject will have hand cultured three times using a cotton swab culture and sent to microbiology for processing. Receives: Other: Chlorhexidine with water rinse |
| Chlorhexidine without water rinse | Experimental | This is an experimental method of disinfection. Following disinfection protocol, each subject will have hand cultured three times using a cotton swab culture and sent to microbiology for processing. Receives: Other: Chlorhexidine without water rinse |
| Chlorhexidine + sterillium hand rub | Active comparator | This is a standard method of disinfection used at NYU Hospital for Joint Disease. Following disinfection protocol, each subject will have hand cultured three times using a cotton swab culture and sent to microbiology for processing. Receives: Other: Chlorhexidine + sterillium hand rub |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of positive cultures in each group
Evaluated using a Students T-test and analysis of variance (ANOVA).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Liporace, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640469
- Sponsor's protocol ID
- 14-00496
- Status last verified
- Jan 2017
- First submitted
- 16 Dec 2015
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Use of Alcohol-bases Solutions Versus Chlorhexidine With or Without Water for Hand Sanitation Prior to Surgical Procedure
- ClinicalTrials.gov ID
- NCT02640469
- Acronym / sponsor ID
- 14-00496
- Conditions
- Infection
- Keywords
- chlorhexidine, sterility, sterile hands
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 29 Dec 2015 (estimated)
- 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.
Currently at NYU institutions, providine-iodine and chlorhexidine medicated soaps are available as hand disinfection options. The purpose of this study is to determine the relative efficacy of traditional hand scrubs with chlorhexidine with or without rinsing with water after scrubbing is complete versus dry hand rubs with alcohol.
Detailed description
No current recommendations exist advocating the use of Providine-iodine or Chlorhexidine. Providine-iodine is safe and effective at reducing skin colonization with gram positive and negative bacteria, mycobacterium tuberculosis, fungi and viruses. Chlorhexidine similarly disrupts cellular membranes. It is bacteriocidal and bacteriostatic and has immediate and more lasting effect than iodine because it can bind to the stratum corneum of the skin and is effective against gram positive and negative organisms, lipophilic viruses and yeasts.
All subjects who are employees of the NYU Hospital for Joint Diseases and have experience with surgical hand disinfection will be asked to enroll. Subjects will be randomized into one of three study arms using an online randomizer: (1) the standard chlorhexidine with water rinse, (2) chlorhexidine without water rinse(experimental), and (3) standard chlorhexidine followed by sterillium hand rub. After hand disinfection protocol has been completed, each subject will have each hand cultured three times using a cotton swab culture stick and sent to the microbiology lab for processing
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine with water rinse | Active comparator | Other: Chlorhexidine with water rinseThis is a traditional method of disinfection used at NYU Hospital for Joint Disease. Following disinfection protocol, each subject will have hand cultured three times using a cotton swab culture and sent to microbiology for processing. |
| Chlorhexidine without water rinse | Experimental | Other: Chlorhexidine without water rinseThis is an experimental method of disinfection. Following disinfection protocol, each subject will have hand cultured three times using a cotton swab culture and sent to microbiology for processing. |
| Chlorhexidine + sterillium hand rub | Active comparator | Other: Chlorhexidine + sterillium hand rubThis is a standard method of disinfection used at NYU Hospital for Joint Disease. Following disinfection protocol, each subject will have hand cultured three times using a cotton swab culture and sent to microbiology for processing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Orthopedic resident or surgical employee of NY U
- Over 21 years of age
- Procedural knowledge of correct aseptic scrub technique
Key exclusion criteria (3 listed)
- No surgical experience
- Under 21 years of age
- Refusal to consent
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 with water rinseThis procedure will be followed for both the right and left hands and arms: scrub each side of finger, in between fingers and back and front of hands for 2 minutes, followed by scrubbing of arms, keeping hands higher than arms at all times, wash each side of the arms from wrist to elbow for 1 minute | Other | Chlorhexidine with water rinse |
| Chlorhexidine without water rinseScrub each side of finger, in between fingers and back and front of hands for 2 minutes, proceed to scrub the arms, keeping the hand higher than the arm at all times, wash each side of the arms from wrist to elbow for 1 minute, and repeat the process on the other arm. | Other | Chlorhexidine without water rinse |
| Chlorhexidine + sterillium hand rubScrub each side of finger, in between fingers and back and front of hands for 2 minutes, Scrub each side of finger, in between fingers and back and front of hands for 2 minutes, proceed to scrub the arms, keeping the hand higher than the arm at all times, wash each side of the arms from wrist to elbow for 1 minute, and repeat the process on the other arm. Rinse hands and arms by passing through water in one direction, dry hands, and rub 5 mL of alcohol into the palm of the hands, forearms and elbows. Ensure that the whole skin area on both arms is covered. | Other | Chlorhexidine + sterillium hand rub |
Primary outcome
Number of positive cultures in each group
Time frame: 1 day
Evaluated using a Students T-test and analysis of variance (ANOVA).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
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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.
Frank Liporace, MD principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine with water rinse, Chlorhexidine without water rinse and Chlorhexidine + sterillium hand rub in people with Infection, run by NYU Langone Health 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 9 Jan 2017. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of positive cultures in each group (time frame: 1 day). 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 9 Jan 2017.