Nosocomial InfectionsNCT00617006
Potential Nosocomial Infection Prevention Via Modification of Anesthesia Intraoperative Aseptic Practice
An observational study of Nosocomial Infections, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
We hypothesized that by improving hand hygiene compliance in the operative environment, we would reduce horizontal transmission of pathogenic bacteria to surgical patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nosocomial Infections
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Oct 2007
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Operating Rooms were randomized and patients in these rooms were enrolled for the study.
Who may be able to join
- Patients present in operating rooms randomized to study.
Who cannot join
- Patients that were already enrolled in study and return to the operating room.
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: Before and After Study Evaluating Deployment of the Sprixx GJ Personal Hand Hygiene Device in the Intra-Operative Environment
We hypothesized that by improving hand hygiene compliance in the operative environment, we would reduce horizontal transmission of pathogenic bacteria to surgical patients.
Read the detailed description
We performed an observational study evaluating provider adherence to these techniques. We then sought to increase hand hygiene compliance through the use of a point of care alcohol based hand hygiene device. We hypothesized that increased hand hygiene compliance would reduce bacterial contamination of the anesthesia workspace and peripheral intravenous tubing, and ultimately reducing overall morbidity and mortality secondary to a reduction in nosocomial infection rates.
- Conditions
- Nosocomial Infections
- Keywords
- Anesthesia Workspace, Hospital Acquired Infections, Hand Hygiene, Alcohol Based Cleanser, Bacterial Contamination
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Before (Control) | Study group representative of standard practice | |
| After(Treatment) | After treatment group with the personal hand hygiene device ie. Device Group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of a positive culture on the previously sterile patient stopcock set, and the presence of multidrug resistant bacteria
Measured: Beginning and end of surgical case
Secondary outcomes (4)
Reduction of bacterial contamination on predetermined sites on the anesthesia machine
Measured: Beginning and End of Surgical Case
Decreased length of stay
Measured: Postoperatively
Nosocomial infection rates
Measured: within 30 days postoperatively
Mortality
Measured: Within 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionAug 2007
- Study completionOct 2007
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 InfectionsStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 114 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-Hitchocck Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617006
- Sponsor's protocol ID
- CPHS# 20655
- Status last verified
- Feb 2008
- First submitted
- 5 Feb 2008
- Last updated
- 15 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Koff MD, Loftus RW, Burchman CC, Schwartzman JD, Read ME, Henry ES, Beach ML. Reduction in intraoperative bacterial contamination of peripheral intravenous tubing through the use of a novel device. Anesthesiology. 2009 May;110(5):978-85. doi: 10.1097/ALN.0b013e3181a06ec3.
PubMed 19352154
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Before and After Study Evaluating Deployment of the Sprixx GJ Personal Hand Hygiene Device in the Intra-Operative Environment
- ClinicalTrials.gov ID
- NCT00617006
- Acronym / sponsor ID
- CPHS# 20655
- Conditions
- Nosocomial Infections
- Keywords
- Anesthesia Workspace, Hospital Acquired Infections, Hand Hygiene, Alcohol Based Cleanser, Bacterial Contamination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Harbor Medical Inc.
- Study start
- Jul 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 15 Feb 2008 (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.
We hypothesized that by improving hand hygiene compliance in the operative environment, we would reduce horizontal transmission of pathogenic bacteria to surgical patients.
Detailed description
We performed an observational study evaluating provider adherence to these techniques. We then sought to increase hand hygiene compliance through the use of a point of care alcohol based hand hygiene device. We hypothesized that increased hand hygiene compliance would reduce bacterial contamination of the anesthesia workspace and peripheral intravenous tubing, and ultimately reducing overall morbidity and mortality secondary to a reduction in nosocomial infection rates.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before (Control) | – | –Study group representative of standard practice |
| After(Treatment) | – | –After treatment group with the personal hand hygiene device ie. Device Group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Operating Rooms were randomized and patients in these rooms were enrolled for the study.
Key inclusion criteria (1 listed)
- Patients present in operating rooms randomized to study.
Key exclusion criteria (1 listed)
- Patients that were already enrolled in study and return to the operating room.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The presence of a positive culture on the previously sterile patient stopcock set, and the presence of multidrug resistant bacteria
Time frame: Beginning and end of surgical case
4 secondary outcomes
Reduction of bacterial contamination on predetermined sites on the anesthesia machine
Time frame: Beginning and End of Surgical Case
Decreased length of stay
Time frame: Postoperatively
Nosocomial infection rates
Time frame: within 30 days postoperatively
Mortality
Time frame: Within 30 days postoperatively
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 15 Feb 2008.
- Derived from this study: PubMed 19352154Koff MD, Loftus RW, Burchman CC, Schwartzman JD, Read ME, Henry ES, Beach ML. Reduction in intraoperative bacterial contamination of peripheral intravenous tubing through the use of a novel device. Anesthesiology. 2009 May;110(5):978-85. doi: 10.1097/ALN.0b013e3181a06ec3.
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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-Hitchocck 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 Infections, 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 15 Feb 2008. 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?
The presence of a positive culture on the previously sterile patient stopcock set, and the presence of multidrug resistant bacteria (time frame: Beginning and end of surgical case). 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 NCT00617006, 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 15 Feb 2008.