NCT01262105

Brief Summary

The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g. bacteria) present at a surgery site during spinal procedures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable surgery

Timeline
Completed

Started Nov 2009

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

November 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2010

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 9, 2012

Completed
Last Updated

April 11, 2012

Status Verified

April 1, 2012

Enrollment Period

11 months

First QC Date

December 15, 2010

Results QC Date

March 14, 2012

Last Update Submit

April 9, 2012

Conditions

Surgery

Keywords

CFUsurgery site

Outcome Measures

Primary Outcomes (1)

  • Surgery Site CFU Density

    CFU culture counts for samples taken in surgery.

    Ten-minute intervals throughout procedure

Study Arms (2)

No device

NO INTERVENTION

Device deployed

EXPERIMENTAL
Device: Air Barrier System Device

Interventions

Air Barrier System DeviceDEVICE

Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the site.

Device deployed

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Candidate for instrumented posterior lumbar interbody fusion

You may not qualify if:

  • Prior history of infection
  • Revision surgery
  • Screens positive for MRSA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Orthopedic Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Stocks GW, Self SD, Thompson B, Adame XA, O'Connor DP. Predicting bacterial populations based on airborne particulates: a study performed in nonlaminar flow operating rooms during joint arthroplasty surgery. Am J Infect Control. 2010 Apr;38(3):199-204. doi: 10.1016/j.ajic.2009.07.006. Epub 2009 Nov 12.

    PMID: 19913327BACKGROUND

Results Point of Contact

Title
Sean Self
Organization
Nimbic Systems
self@nimbicsystems.com
281-565-5700

Study Officials

  • David Wimberley, MD

    Fondren Orthopaedic Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2010

First Posted

December 17, 2010

Study Start

November 1, 2009

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

April 11, 2012

Results First Posted

April 9, 2012

Record last verified: 2012-04

Locations

US(1)