Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery

NCT ID: NCT01559506

Last Updated: 2015-03-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-02-28

Brief Summary

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

Detailed Description

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The ABS 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 ABS can reduce the presence of airborne colony-forming units at the surgery site during posterior 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

Subject does not receive ABS system

Group Type NO_INTERVENTION

No interventions assigned to this group

Air Barrier System device

Device is deployed adjacent to the surgery site and activated.

Group Type EXPERIMENTAL

Air Barrier System device

Intervention Type DEVICE

Device is deployed adjacent to the surgery site and activated.

Interventions

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Air Barrier System device

Device is deployed adjacent to the surgery site and activated.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult patients undergoing lumbar and cervical laminectomy with instrumentation.

Exclusion Criteria

* Active infection
* Prior prosthesis infection
Minimum Eligible Age

18 Years

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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Rabih O Darouiche, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Sean Self

Role: PRINCIPAL_INVESTIGATOR

Nimbic Systems

Locations

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Michael E. DeBakey VA Medical Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ABS-003

Identifier Type: -

Identifier Source: org_study_id

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