Evaluation of Body-worn Multimodal Hand Hygiene System. I... | NCT01050608

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Dec 2009Actual

Completion Date

Jan 2011Actual

First Submitted Date

Jan 14, 2010

First Submission Date that Met QC Criteria

Jan 14, 2010

First Posted Date

Jan 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2011

Last Update Posted Date

Jun 23, 2011Estimated

Name	Class
Harbor Medical Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,954Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sprixx Device Group		Treatment group utilizing multimodal hand hygiene device	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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Body worn alcohol gel dispenser	Device	Records hand hygiene events of provider and tabulates on the group level.	Sprixx Device Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in healthcare associated infections (CRBSI and VAP)		2 years

Secondary Outcomes

Measure	Description	Time Frame
Time to infections Hospital mortality Length of stay		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All ICU patients

Exclusion Criteria:

Patient is not in an ICU at our Institution

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Intensive Care Unit Patients Multidisciplinary Intensive Care Unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew D. Koff, M.D. M.S.	Dartmouth-Hitchcock Medical Center	Principal Investigator
Randy L Loftus, M.D.	Dartmouth-Hitchcock Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dartmouth-HItchcock Medical Center		Lebanon	New Hampshire	03756	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	Anesthesiology 2008; 109 A54 ASA Abstracts

ID	Term
D007239	Infections
D007049	Iatrogenic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms