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Evaluating the Impact That Personnel Traffic Through the Operating Room Has on Surgical Site Infections (BRITE)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier:
NCT01783769
First received: February 1, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

All eligible patients who will have neurosurgery at Barrow Neurological Institute (BNI) between March 1, 2013 and February 28, 2014 will be enrolled as part of this study that will look at the flow of staff people in and out of the operating room during surgeries and the effect that the number of people may have on the rate of infections in the surgical sites.


Condition Intervention
Neurological Diseases
Behavioral: "Low O.R. Traffic"

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Barrow Randomized O.R. Traffic Trial

Resource links provided by NLM:


Further study details as provided by St. Joseph's Hospital and Medical Center, Phoenix:

Primary Outcome Measures:
  • Return to BNI O.R. for wound washout [ Time Frame: within 12 months of study entry ] [ Designated as safety issue: Yes ]
    A patient returns to the BNI O.R. with surgical site infection requiring a wound washout procedure.


Secondary Outcome Measures:
  • Return to the BNI O.R. for any reason [ Time Frame: within 12 months of study entry ] [ Designated as safety issue: Yes ]
    The patient returns to the BNI O.R. for surgery for any reason


Estimated Enrollment: 6000
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Normal O.R. Traffic
This "Normal O.R. Traffic" protocol follows the national standards of care.
Active Comparator: "Low O.R. Traffic"
This protocol will restrict personnel movement thru the operating room to a "bare minimum" of personnel traffic.
Behavioral: "Low O.R. Traffic"
"Low OR Traffic" protocol will restrict personnel movement thru the operating room to a "bare minimum" of personnel traffic.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject undergoing a surgical procedure that will disrupt the epithelial lining of the subject's body.
  • The subject's procedure must occur within 1 of the 11 BNI Operating Rooms

Exclusion Criteria:

  • Subjects undergoing procedures within the BNI Operating Rooms that do not disrupt the epithelial lining of the subject's body
  • Subjects undergoing surgical procedures outside of the BNI Operating Rooms
  • Pregnant women
  • Prison inmates
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783769

Locations
United States, Arizona
Barrow Neurological Institute at St.Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Investigators
Principal Investigator: Robert F. Spetzler, MD St. Joseph's Hospital and Medical Center, Phoenix
  More Information

No publications provided

Responsible Party: St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT01783769     History of Changes
Other Study ID Numbers: BRITE Trial
Study First Received: February 1, 2013
Last Updated: April 14, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by St. Joseph's Hospital and Medical Center, Phoenix:
neurosurgery
operating room personnel
sterile procedures
infection
Conditions requiring surgery

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2014