NCT01783769

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,944

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

February 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2013

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

3.3 years

First QC Date

February 1, 2013

Last Update Submit

August 9, 2017

Conditions

Neurological Diseases

Keywords

neurosurgeryoperating room personnelsterile proceduresinfectionConditions requiring surgery

Outcome Measures

Primary Outcomes (1)

  • Return to BNI O.R. for wound washout

    A patient returns to the BNI O.R. with surgical site infection requiring a wound washout procedure.

    within 12 months of study entry

Secondary Outcomes (1)

  • Return to the BNI O.R. for any reason

    within 12 months of study entry

Study Arms (2)

Normal O.R. Traffic

NO INTERVENTION

This "Normal O.R. Traffic" protocol follows the national standards of care.

"Low O.R. Traffic"

ACTIVE COMPARATOR

This protocol will restrict personnel movement thru the operating room to a "bare minimum" of personnel traffic.

Behavioral: "Low O.R. Traffic"

Interventions

"Low O.R. Traffic"BEHAVIORAL

"Low OR Traffic" protocol will restrict personnel movement thru the operating room to a "bare minimum" of personnel traffic.

"Low O.R. Traffic"

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barrow Neurological Institute at St.Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Robert F. Spetzler, MD

    St. Joseph's Hospital and Medical Center, Phoenix

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2013

First Posted

February 5, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 11, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)