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Efficacy of Surgical Preparations in Lumbar Spine Surgery

This study has been completed.
Information provided by:
Northwestern University Identifier:
First received: April 12, 2010
Last updated: November 16, 2010
Last verified: November 2010
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).

Condition Intervention
Infection Other: DuraPrep Other: ChloraPrep

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Surgical Preparations in Lumbar Spine Surgery

Resource links provided by NLM:

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Positive culture results [ Time Frame: 7 days ]
    Our primary outcome measure is positive aerobic and/or anaerobic cultures reported at 7 days.

Estimated Enrollment: 100
Study Start Date: January 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DuraPrep Other: DuraPrep
DuraPrep is used for skin preparation prior to surgery.
Active Comparator: ChloraPrep Other: ChloraPrep
ChloraPrep is used for skin preparation prior to surgery.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01105195

United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
  More Information

Additional Information:
Responsible Party: Michael Haak, MD, Northwestern University Feinberg School of Medicine Identifier: NCT01105195     History of Changes
Other Study ID Numbers: STU00008875
Study First Received: April 12, 2010
Last Updated: November 16, 2010

Keywords provided by Northwestern University:
Lumbar Spine

Additional relevant MeSH terms:
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents
Trace Elements
Growth Substances
Physiological Effects of Drugs processed this record on August 17, 2017