Efficacy of Surgical Preparations in Lumbar Spine Surgery

Northwestern University

Status: Completed

Conditions: Infection

Treatments: Other: DuraPrep; Other: ChloraPrep

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01105195

STU00008875

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

DuraPrep

Active Comparator group

Treatment:

Other: DuraPrep

ChloraPrep

Active Comparator group

Treatment:

Other: ChloraPrep