NCT00617006

Brief Summary

We hypothesized that by improving hand hygiene compliance in the operative environment, we would reduce horizontal transmission of pathogenic bacteria to surgical patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
Last Updated

February 15, 2008

Status Verified

February 1, 2008

Enrollment Period

1 month

First QC Date

February 5, 2008

Last Update Submit

February 14, 2008

Conditions

Nosocomial Infections

Keywords

Anesthesia WorkspaceHospital Acquired InfectionsHand HygieneAlcohol Based CleanserBacterial Contamination

Outcome Measures

Primary Outcomes (1)

  • The presence of a positive culture on the previously sterile patient stopcock set, and the presence of multidrug resistant bacteria

    Beginning and end of surgical case

Secondary Outcomes (4)

  • Reduction of bacterial contamination on predetermined sites on the anesthesia machine

    Beginning and End of Surgical Case

  • Decreased length of stay

    Postoperatively

  • Nosocomial infection rates

    within 30 days postoperatively

  • Mortality

    Within 30 days postoperatively

Study Arms (2)

Before (Control)

Study group representative of standard practice

After(Treatment)

After treatment group with the personal hand hygiene device ie. Device Group.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Operating Rooms were randomized and patients in these rooms were enrolled for the study.

You may qualify if:

  • Patients present in operating rooms randomized to study.

You may not qualify if:

  • Patients that were already enrolled in study and return to the operating room.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

  • 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.

    PMID: 19352154DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Environmental Bacterial Samples of Workspace

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Matthew D Koff, M.D. M.S.

    Dartmouth-Hitchocck Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2008

First Posted

February 15, 2008

Study Start

July 1, 2007

Primary Completion

August 1, 2007

Study Completion

October 1, 2007

Last Updated

February 15, 2008

Record last verified: 2008-02

Locations

US(1)