Nosocomial InfectionSprixx-ICUNCT01050608
Evaluation of Body-worn Multimodal Hand Hygiene System. Impact on Health-Care Associated Infections
An observational study of Nosocomial Infection, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Evaluate the efficacy of a multimodal hand hygiene system in the intensive care unit environment and evaluate any impact on health care associated infections. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nosocomial Infection
- What is being tested?
- Body worn alcohol gel dispenser, 62% ethanol based hand cleanser and Educational component with regard to teaching CDC guidelines
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 2,954 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jan 2011
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Intensive Care Unit Patients Multidisciplinary Intensive Care Unit
Who may be able to join
- All ICU patients
Who cannot join
- Patient is not in an ICU at our Institution
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-HItchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: Real Time Deployment of Multimodal Personal Dispenser Hand Hygiene System in a Multidisciplinary Intensive Care Unit.
Evaluate the efficacy of a multimodal hand hygiene system in the intensive care unit environment and evaluate any impact on health care associated infections.
Read the detailed description
Deploy and utilize a novel body worn hand hygiene system that incorporates provider and group specific feedback allowing hand hygiene to occur directly within the patient environment. We hypothesize that by improving provider hand hygiene we will reduce health-care associated infection rates.
- Conditions
- Nosocomial Infection
- Being tested
- Body worn alcohol gel dispenser, 62% ethanol based hand cleanser, Educational component with regard to teaching CDC guidelines, Provider and group feedback
- Keywords
- Alcohol Rub, Hand Hygiene, Provider Feedback, Health Care Associated Infections
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body worn alcohol gel dispenserDevice
Records hand hygiene events of provider and tabulates on the group level.
62% ethanol based hand cleanserDrug
CDC based guidelines with regard to utilization in the health care environment "the nest"
Educational component with regard to teaching CDC guidelinesBehavioural
12 minute education prior to deploying device for all providers.
Provider and group feedbackBehavioural
Provide feedback with regard to expected hand hygiene goals to providers and reported anonymous group results based on recorded information.
| Study group | Role | What they receive |
|---|---|---|
| Sprixx Device Group | Treatment group utilizing multimodal hand hygiene device Receives: Device: Body worn alcohol gel dispenser; Drug: 62% ethanol based hand cleanser; Behavioral: Educational component with regard to teaching CDC guidelines; Behavioral: Provider and group feedback | |
| Standard Hand Hygiene Group | Utilizing wall mounted dispensers and CDC based guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in healthcare associated infections (CRBSI and VAP)
Measured: 2 years
Secondary outcomes (1)
Time to infections Hospital mortality Length of stay
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startDec 2007
- Primary completionDec 2009
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nosocomial InfectionStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,954 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Harbor Medical Inc.
- Investigators
- Matthew D. Koff, M.D. M.S., Principal investigator, Dartmouth-Hitchcock Medical CenterRandy L Loftus, M.D., Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050608
- Sponsor's protocol ID
- 20655-ICU extension
- Acronym
- Sprixx-ICU
- Status last verified
- Jun 2011
- First submitted
- 14 Jan 2010
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Anesthesiology 2008; 109 A54 ASA Abstracts
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Time Deployment of Multimodal Personal Dispenser Hand Hygiene System in a Multidisciplinary Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT01050608
- Acronym / sponsor ID
- Sprixx-ICU / 20655-ICU extension
- Conditions
- Nosocomial Infection
- Keywords
- Alcohol Rub, Hand Hygiene, Provider Feedback, Health Care Associated Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,954 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Harbor Medical Inc.
- Study start
- Dec 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 15 Jan 2010 (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.
Evaluate the efficacy of a multimodal hand hygiene system in the intensive care unit environment and evaluate any impact on health care associated infections.
Detailed description
Deploy and utilize a novel body worn hand hygiene system that incorporates provider and group specific feedback allowing hand hygiene to occur directly within the patient environment. We hypothesize that by improving provider hand hygiene we will reduce health-care associated infection rates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sprixx Device Group | – | Device: Body worn alcohol gel dispenser, Drug: 62% ethanol based hand cleanser, Behavioral: Educational component with regard to teaching CDC guidelines, Behavioral: Provider and group feedbackTreatment group utilizing multimodal hand hygiene device |
| Standard Hand Hygiene Group | – | –Utilizing wall mounted dispensers and CDC based guidelines. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Intensive Care Unit Patients Multidisciplinary Intensive Care Unit
Key inclusion criteria (1 listed)
- All ICU patients
Key exclusion criteria (1 listed)
- Patient is not in an ICU at our Institution
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 |
|---|---|---|
| Body worn alcohol gel dispenserRecords hand hygiene events of provider and tabulates on the group level. | Device | Sprixx Device Group |
| 62% ethanol based hand cleanserCDC based guidelines with regard to utilization in the health care environment "the nest" | Drug | Sprixx Device Group |
| Educational component with regard to teaching CDC guidelines12 minute education prior to deploying device for all providers. | Behavioural | Sprixx Device Group |
| Provider and group feedbackProvide feedback with regard to expected hand hygiene goals to providers and reported anonymous group results based on recorded information. | Behavioural | Sprixx Device Group |
Primary outcome
Reduction in healthcare associated infections (CRBSI and VAP)
Time frame: 2 years
1 secondary outcome
Time to infections Hospital mortality Length of stay
Time frame: 2 years
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 23 Jun 2011.
- Results publicationAnesthesiology 2008; 109 A54 ASA Abstracts
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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.
Matthew D. Koff, M.D. M.S. principal investigator
Dartmouth-Hitchcock Medical Center
Randy L Loftus, M.D. principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nosocomial Infection, run by Dartmouth-Hitchcock 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 1 inclusion and 1 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 23 Jun 2011. 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 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?
Reduction in healthcare associated infections (CRBSI and VAP) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01050608, which also lists 1 linked publication.
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 Jun 2011.