Efficacy of Surgical Preparations in Lumbar Spine Surgery

NCT ID: NCT01105195

Last Updated: 2010-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-11-30

Brief Summary

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The purpose of this study is to 1) identify the common bacterial flora found on the skin overlying the lumbar spine, and 2) evaluate the efficacy of readily available skin-preparation solutions in the elimination of bacterial pathogens from the surgical site following skin preparation (DuraPrep versus ChloraPrep).

Detailed Description

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Conditions

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Infection

Keywords

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DuraPrep ChloraPrep Lumbar Spine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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DuraPrep

Group Type ACTIVE_COMPARATOR

DuraPrep

Intervention Type OTHER

DuraPrep is used for skin preparation prior to surgery.

ChloraPrep

Group Type ACTIVE_COMPARATOR

ChloraPrep

Intervention Type OTHER

ChloraPrep is used for skin preparation prior to surgery.

Interventions

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DuraPrep

DuraPrep is used for skin preparation prior to surgery.

Intervention Type OTHER

ChloraPrep

ChloraPrep is used for skin preparation prior to surgery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All patients undergoing lumbar spine surgery (discectomy, laminectomy, fusion, etc).

Exclusion Criteria

* Open wound at the incision site,
* Abrasion in the vicinity of the incision site,
* An active infection at or near the surgical site, or
* An active infection elsewhere in the body.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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3M

INDUSTRY

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Northwestern University Feinberg School of Medicine

Locations

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Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009 Aug;91(8):1949-53. doi: 10.2106/JBJS.H.00768.

Reference Type BACKGROUND
PMID: 19651954 (View on PubMed)

Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005 May;87(5):980-5. doi: 10.2106/JBJS.D.01977.

Reference Type BACKGROUND
PMID: 15866959 (View on PubMed)

Related Links

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Other Identifiers

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STU00008875

Identifier Type: -

Identifier Source: org_study_id