Device to Reduce Surgery Site Contamination - Spine

NCT ID: NCT01262105

Last Updated: 2012-04-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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The Air Barrier System is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the Air Barrier System can reduce the presence of airborne colony-forming units at the surgery site during spinal procedures.

Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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No device

Group Type NO_INTERVENTION

No interventions assigned to this group

Device deployed

Group Type EXPERIMENTAL

Air Barrier System Device

Intervention Type DEVICE

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

Interventions

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Air Barrier System Device

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Candidate for instrumented posterior lumbar interbody fusion

Exclusion Criteria

* Prior history of infection
* Revision surgery
* Screens positive for MRSA
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nimbic Systems, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Wimberley, MD

Role: PRINCIPAL_INVESTIGATOR

Fondren Orthopaedic Group

Locations

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Texas Orthopedic Hospital

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19913327 (View on PubMed)

Other Identifiers

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ABS-002

Identifier Type: -

Identifier Source: org_study_id

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